0 Ratings
ID

44320

Description

Optimization of the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure; ODM derived from: https://clinicaltrials.gov/show/NCT02481219

Link

https://clinicaltrials.gov/show/NCT02481219

Keywords

Versions (2)
  1. 3/3/19 3/3/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Colorectal Cancer Screening NCT02481219

    English

    Eligibility Colorectal Cancer Screening NCT02481219

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. subject is between 50 and 75 years of age.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. subject is classified as average risk per the american gastroenterological association guidelines on colorectal cancer screening: individuals without a personal or family history of crc or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
    Description

    Average Risk Colorectal Carcinoma | Medical History Absent Colorectal Carcinoma | Family history of colorectal cancer Absent | Medical History Absent Adenoma | Family history Absent Adenoma | Medical History Absent Inflammatory Bowel Diseases | Family history of inflammatory bowel disease Absent | Medical History Absent High risk Genetic syndrome | Family history Absent High risk Genetic syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1510992
    UMLS CUI [1,2]
    C0035647
    UMLS CUI [1,3]
    C0009402
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [2,3]
    C0009402
    UMLS CUI [3,1]
    C3266797
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4,1]
    C0262926
    UMLS CUI [4,2]
    C0332197
    UMLS CUI [4,3]
    C0001430
    UMLS CUI [5,1]
    C0241889
    UMLS CUI [5,2]
    C0332197
    UMLS CUI [5,3]
    C0001430
    UMLS CUI [6,1]
    C0262926
    UMLS CUI [6,2]
    C0332197
    UMLS CUI [6,3]
    C0021390
    UMLS CUI [7,1]
    C3887081
    UMLS CUI [7,2]
    C0332197
    UMLS CUI [8,1]
    C0262926
    UMLS CUI [8,2]
    C0332197
    UMLS CUI [8,3]
    C4319571
    UMLS CUI [8,4]
    C0019247
    UMLS CUI [9,1]
    C0241889
    UMLS CUI [9,2]
    C0332197
    UMLS CUI [9,3]
    C4319571
    UMLS CUI [9,4]
    C0019247
    3. subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. subject with history of polyps (including those identified by computed tomography [ct], optical colonoscopy, sigmoidoscopy, etc.).
    Description

    Medical History Polyps | Polyps CT | Polyps Colonoscopy | Polyps Sigmoidoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0032584
    UMLS CUI [2,1]
    C0032584
    UMLS CUI [2,2]
    C0040405
    UMLS CUI [3,1]
    C0032584
    UMLS CUI [3,2]
    C0009378
    UMLS CUI [4,1]
    C0032584
    UMLS CUI [4,2]
    C0037075
    2. subject with history of negative colon assessment (including ct, optical colonoscopy, sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring screening in this time frame.
    Description

    Colon Assessment Negative | Colon Assessment Negative CT | Colon Assessment Negative Colonoscopy | Colon Assessment Negative Sigmoidoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009368
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [1,3]
    C1513916
    UMLS CUI [2,1]
    C0009368
    UMLS CUI [2,2]
    C1516048
    UMLS CUI [2,3]
    C1513916
    UMLS CUI [2,4]
    C0040405
    UMLS CUI [3,1]
    C0009368
    UMLS CUI [3,2]
    C1516048
    UMLS CUI [3,3]
    C1513916
    UMLS CUI [3,4]
    C0009378
    UMLS CUI [4,1]
    C0009368
    UMLS CUI [4,2]
    C1516048
    UMLS CUI [4,3]
    C1513916
    UMLS CUI [4,4]
    C0037075
    3. subject with suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
    Description

    Hematochezia Suspected | Hematochezia | Melena Suspected | Melena | Iron deficiency Suspected | Iron deficiency | Anemia | Anemia Absent | Rectal hemorrhage | Positive fecal occult blood test

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018932
    UMLS CUI [1,2]
    C0750491
    UMLS CUI [2]
    C0018932
    UMLS CUI [3,1]
    C0025222
    UMLS CUI [3,2]
    C0750491
    UMLS CUI [4]
    C0025222
    UMLS CUI [5,1]
    C0240066
    UMLS CUI [5,2]
    C0750491
    UMLS CUI [6]
    C0240066
    UMLS CUI [7]
    C0002871
    UMLS CUI [8,1]
    C0002871
    UMLS CUI [8,2]
    C0332197
    UMLS CUI [9]
    C0267596
    UMLS CUI [10]
    C4062677
    4. subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
    Description

    Condition At risk Capsule Retention | Intestinal Obstruction Suspected | Intestinal Obstruction | Bowel stricture Suspected | Bowel stricture | Intestinal Fistula Suspected | Intestinal Fistula

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C0006935
    UMLS CUI [1,4]
    C0333117
    UMLS CUI [2,1]
    C0021843
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [3]
    C0021843
    UMLS CUI [4,1]
    C1394745
    UMLS CUI [4,2]
    C0750491
    UMLS CUI [5]
    C1394745
    UMLS CUI [6,1]
    C0021833
    UMLS CUI [6,2]
    C0750491
    UMLS CUI [7]
    C0021833
    5. subject with dysphagia or any swallowing disorder.
    Description

    Deglutition Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011168
    6. subject with serious medical conditions that would increase the risk associated with capsule or colonoscopy that are so severe that screening would have no benefit.
    Description

    Medical condition Serious At risk Capsule | Medical condition Serious At risk Colonoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [1,4]
    C0006935
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C1444641
    UMLS CUI [2,4]
    C0009378
    7. subject with a cardiac pacemaker or other implanted electromedical device.
    Description

    Artificial cardiac pacemaker | Implanted medical device Electrical

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    UMLS CUI [2,1]
    C2735362
    UMLS CUI [2,2]
    C0442828
    8. subject expected to undergo mri examination within 7 days after ingestion of the capsule.
    Description

    Magnetic Resonance Imaging Expected

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C1517001
    9. subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (bun), and/or glomerular filtration rate (gfr) outside of the local laboratory reference range.
    Description

    Kidney Disease | Abnormal renal function | Serum creatinine abnormal | Blood urea abnormal | Abnormal glomerular filtration rate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    UMLS CUI [2]
    C0151746
    UMLS CUI [3]
    C0438243
    UMLS CUI [4]
    C0438242
    UMLS CUI [5]
    C0854050
    10. subject with known gastrointestinal motility disorders.
    Description

    Gastrointestinal motility disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0854121
    11. subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.
    Description

    Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0013230
    12. subject with comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
    Description

    Comorbidity Study Subject Participation Status Inappropriate | Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1548788
    UMLS CUI [2]
    C0023671
    13. subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
    Description

    Vulnerable Population | Prisoners | Mental impairment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0949366
    UMLS CUI [2]
    C0033167
    UMLS CUI [3]
    C0683322
    14. subject is pregnant, suspected pregnant, or is actively breast-feeding. females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).
    Description

    Pregnancy | Pregnancy Suspected | Breast Feeding | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test | Exception Female Sterilization | Exception Postmenopausal state

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [3]
    C0006147
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0430056
    UMLS CUI [5,1]
    C3831118
    UMLS CUI [5,2]
    C0430064
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0015787
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0232970
    15. subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.
    Description

    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Interference Patient safety

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    UMLS CUI [3]
    C2346570
    UMLS CUI [4,1]
    C0521102
    UMLS CUI [4,2]
    C1113679
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    Similar models

    Eligibility Colorectal Cancer Screening NCT02481219

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. subject is between 50 and 75 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Average Risk Colorectal Carcinoma | Medical History Absent Colorectal Carcinoma | Family history of colorectal cancer Absent | Medical History Absent Adenoma | Family history Absent Adenoma | Medical History Absent Inflammatory Bowel Diseases | Family history of inflammatory bowel disease Absent | Medical History Absent High risk Genetic syndrome | Family history Absent High risk Genetic syndrome
    Item
    2. subject is classified as average risk per the american gastroenterological association guidelines on colorectal cancer screening: individuals without a personal or family history of crc or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
    boolean
    C1510992 (UMLS CUI [1,1])
    C0035647 (UMLS CUI [1,2])
    C0009402 (UMLS CUI [1,3])
    C0262926 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0009402 (UMLS CUI [2,3])
    C3266797 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0262926 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    C0001430 (UMLS CUI [4,3])
    C0241889 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    C0001430 (UMLS CUI [5,3])
    C0262926 (UMLS CUI [6,1])
    C0332197 (UMLS CUI [6,2])
    C0021390 (UMLS CUI [6,3])
    C3887081 (UMLS CUI [7,1])
    C0332197 (UMLS CUI [7,2])
    C0262926 (UMLS CUI [8,1])
    C0332197 (UMLS CUI [8,2])
    C4319571 (UMLS CUI [8,3])
    C0019247 (UMLS CUI [8,4])
    C0241889 (UMLS CUI [9,1])
    C0332197 (UMLS CUI [9,2])
    C4319571 (UMLS CUI [9,3])
    C0019247 (UMLS CUI [9,4])
    Informed Consent
    Item
    3. subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Medical History Polyps | Polyps CT | Polyps Colonoscopy | Polyps Sigmoidoscopy
    Item
    1. subject with history of polyps (including those identified by computed tomography [ct], optical colonoscopy, sigmoidoscopy, etc.).
    boolean
    C0262926 (UMLS CUI [1,1])
    C0032584 (UMLS CUI [1,2])
    C0032584 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    C0032584 (UMLS CUI [3,1])
    C0009378 (UMLS CUI [3,2])
    C0032584 (UMLS CUI [4,1])
    C0037075 (UMLS CUI [4,2])
    Colon Assessment Negative | Colon Assessment Negative CT | Colon Assessment Negative Colonoscopy | Colon Assessment Negative Sigmoidoscopy
    Item
    2. subject with history of negative colon assessment (including ct, optical colonoscopy, sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring screening in this time frame.
    boolean
    C0009368 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C1513916 (UMLS CUI [1,3])
    C0009368 (UMLS CUI [2,1])
    C1516048 (UMLS CUI [2,2])
    C1513916 (UMLS CUI [2,3])
    C0040405 (UMLS CUI [2,4])
    C0009368 (UMLS CUI [3,1])
    C1516048 (UMLS CUI [3,2])
    C1513916 (UMLS CUI [3,3])
    C0009378 (UMLS CUI [3,4])
    C0009368 (UMLS CUI [4,1])
    C1516048 (UMLS CUI [4,2])
    C1513916 (UMLS CUI [4,3])
    C0037075 (UMLS CUI [4,4])
    Hematochezia Suspected | Hematochezia | Melena Suspected | Melena | Iron deficiency Suspected | Iron deficiency | Anemia | Anemia Absent | Rectal hemorrhage | Positive fecal occult blood test
    Item
    3. subject with suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
    boolean
    C0018932 (UMLS CUI [1,1])
    C0750491 (UMLS CUI [1,2])
    C0018932 (UMLS CUI [2])
    C0025222 (UMLS CUI [3,1])
    C0750491 (UMLS CUI [3,2])
    C0025222 (UMLS CUI [4])
    C0240066 (UMLS CUI [5,1])
    C0750491 (UMLS CUI [5,2])
    C0240066 (UMLS CUI [6])
    C0002871 (UMLS CUI [7])
    C0002871 (UMLS CUI [8,1])
    C0332197 (UMLS CUI [8,2])
    C0267596 (UMLS CUI [9])
    C4062677 (UMLS CUI [10])
    Condition At risk Capsule Retention | Intestinal Obstruction Suspected | Intestinal Obstruction | Bowel stricture Suspected | Bowel stricture | Intestinal Fistula Suspected | Intestinal Fistula
    Item
    4. subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
    boolean
    C0348080 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C0006935 (UMLS CUI [1,3])
    C0333117 (UMLS CUI [1,4])
    C0021843 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0021843 (UMLS CUI [3])
    C1394745 (UMLS CUI [4,1])
    C0750491 (UMLS CUI [4,2])
    C1394745 (UMLS CUI [5])
    C0021833 (UMLS CUI [6,1])
    C0750491 (UMLS CUI [6,2])
    C0021833 (UMLS CUI [7])
    Deglutition Disorder
    Item
    5. subject with dysphagia or any swallowing disorder.
    boolean
    C0011168 (UMLS CUI [1])
    Medical condition Serious At risk Capsule | Medical condition Serious At risk Colonoscopy
    Item
    6. subject with serious medical conditions that would increase the risk associated with capsule or colonoscopy that are so severe that screening would have no benefit.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0006935 (UMLS CUI [1,4])
    C3843040 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    C0009378 (UMLS CUI [2,4])
    Artificial cardiac pacemaker | Implanted medical device Electrical
    Item
    7. subject with a cardiac pacemaker or other implanted electromedical device.
    boolean
    C0030163 (UMLS CUI [1])
    C2735362 (UMLS CUI [2,1])
    C0442828 (UMLS CUI [2,2])
    Magnetic Resonance Imaging Expected
    Item
    8. subject expected to undergo mri examination within 7 days after ingestion of the capsule.
    boolean
    C0024485 (UMLS CUI [1,1])
    C1517001 (UMLS CUI [1,2])
    Kidney Disease | Abnormal renal function | Serum creatinine abnormal | Blood urea abnormal | Abnormal glomerular filtration rate
    Item
    9. subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (bun), and/or glomerular filtration rate (gfr) outside of the local laboratory reference range.
    boolean
    C0022658 (UMLS CUI [1])
    C0151746 (UMLS CUI [2])
    C0438243 (UMLS CUI [3])
    C0438242 (UMLS CUI [4])
    C0854050 (UMLS CUI [5])
    Gastrointestinal motility disorder
    Item
    10. subject with known gastrointestinal motility disorders.
    boolean
    C0854121 (UMLS CUI [1])
    Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs
    Item
    11. subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    Comorbidity Study Subject Participation Status Inappropriate | Life Expectancy
    Item
    12. subject with comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
    boolean
    C0009488 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1548788 (UMLS CUI [1,3])
    C0023671 (UMLS CUI [2])
    Vulnerable Population | Prisoners | Mental impairment
    Item
    13. subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
    boolean
    C0949366 (UMLS CUI [1])
    C0033167 (UMLS CUI [2])
    C0683322 (UMLS CUI [3])
    Pregnancy | Pregnancy Suspected | Breast Feeding | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test | Exception Female Sterilization | Exception Postmenopausal state
    Item
    14. subject is pregnant, suspected pregnant, or is actively breast-feeding. females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).
    boolean
    C0032961 (UMLS CUI [1])
    C0032961 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0006147 (UMLS CUI [3])
    C3831118 (UMLS CUI [4,1])
    C0430056 (UMLS CUI [4,2])
    C3831118 (UMLS CUI [5,1])
    C0430064 (UMLS CUI [5,2])
    C1705847 (UMLS CUI [6,1])
    C0015787 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0232970 (UMLS CUI [7,2])
    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Interference Patient safety
    Item
    15. subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    C2346570 (UMLS CUI [3])
    C0521102 (UMLS CUI [4,1])
    C1113679 (UMLS CUI [4,2])
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