Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-006933
NCT ID: NCT03241368
Sponsor Protocol Number: COVSBCC0549
About this study
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ups along with a Quality of Life questionnaire at 12 month follow up. Concomitant medication and adverse events information will be collected baseline and 3-, 6-, 9- and 12 month follow ups.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject has provided informed consent.
- Subject is ≥ 18 years of age
- Subject is willing and able to comply with all aspects of treatment and evaluation schedule.
- Subject has known CD and a recent history (within last 2 years) of mucosal disease (diagnosis based on radiologic, endoscopic, or histological evidence).
Exclusion Criteria:
- Subject has indeterminate, ulcerative, antibiotic-associated colitis.
- Subject has stool positive for ova and parasite and for Clostridium difficule toxins within 3 months prior to enrollment.
- Subject with other known infectious cause of abdominal symptoms.
- Subject with clinical evidence of renal disease with the past 6 months, defined as estimated glomerular filtration rate (GFR) outside the normal reference range.
- Subject with known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
- Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.
- Subjects with a history of small bowel or colonic resection.
- Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
- Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (< 100 mg daily) are acceptable and not exclusionary.
- Subject suffers from any condition, such as swallowing problems, that precludes compliance with study and/or device instructions.
- Subject with cardiac pacemaker or other implanted electromedical device.
- Subject has an allergy or other known contraindication to the medications used in the study.
- Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
- Subject is considered to be a part of a vulnerable population (eg. prisoners or those without sufficient mental capacity).
- Subject has a known contraindication to MRE or IC.
- Subject has participated in a drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in the study.
- Subject has any medical condition that would make it unsafe for them to participate, per Investigator's descretion
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator David Bruining, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available