ID

35372

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02481219

Keywords

versioni (2)
  1. 03/03/19 03/03/19 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

3 marzo 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Colorectal Cancer Screening NCT02481219

Inglese

Eligibility Colorectal Cancer Screening NCT02481219

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Age

Tipo di dati

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.
Descrizione

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

Tipo di dati

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]
C0567439
UMLS CUI [9,1]
C0241889
UMLS CUI [9,2]
C0332197
UMLS CUI [9,3]
C4319571
UMLS CUI [9,4]
C0567439
3. subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

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

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Deglutition Disorder

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Artificial cardiac pacemaker | Implanted medical device Electrical

Tipo di dati

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.
Descrizione

Magnetic Resonance Imaging Expected

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Gastrointestinal motility disorder

Tipo di dati

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.
Descrizione

Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs

Tipo di dati

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.
Descrizione

Comorbidity Study Subject Participation Status Inappropriate | Life Expectancy

Tipo di dati

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).
Descrizione

Vulnerable Population | Prisoners | Mental impairment

Tipo di dati

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).
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
C0567439 (UMLS CUI [8,4])
C0241889 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C4319571 (UMLS CUI [9,3])
C0567439 (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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