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])
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])