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.

Completed · Not applicable

Conditions studied: Crohn Disease

In brief

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. Patient satisfaction questionnaire will be completed at baseline.

Key facts

Study ID: NCT03241368
Run by: Medtronic - MITG
People needed: 187
Starts: 2017-12-21
Expected to finish: 2019-06-20
Last updated by the study team: 2020-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 (based on radiologic, endoscopic, or histologic evidence) OR known CD and active disease, based on clinical judgment based on symptoms, laboratory data or other clinical information.

You may not qualify if…

Subject has indeterminate, ulcerative, antibiotic-associated colitis.
Subject has stool positive for ova and parasite and for Clostridium difficile 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.
Subject with suspected or known bowel obstruction, stricture (defined as unequivocal proximal upstream dilation equal ≥ 2.5 cm), 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 discretion
Subject with ileostomy or colostomy, history of total or subtotal colectomy (including those with ileosigmoidostomy, and ileorectostomy)

Where it is running

University of South Alabama — Mobile, Alabama, United States
Mayo Clinic (Scottsdale, AZ) — Scottsdale, Arizona, United States
Encore Borland Groover Clinical Research — Jacksonville, Florida, United States
Children's Center for Digestive Healthcare — Atlanta, Georgia, United States
Loyola University - Chicago — Maywood, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
University of Kansas — Kansas City, Kansas, United States
Louisiana State University Health Science Center — New Orleans, Louisiana, United States
University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Mayo Clinic (Rochester, MN) — Rochester, Minnesota, United States
Washington University — St Louis, Missouri, United States
Atlantic Health (Morristown) — Morristown, New Jersey, United States
Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
The Ohio State University Medical Center — Columbus, Ohio, United States
Digestive Disease Specialists Inc. — Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Gastroenterology Associates of Tidewater — Chesapeake, Virginia, United States
Carilion Clinic — Roanoke, Virginia, United States
Virginia Gastroenterology Institute — Suffolk, Virginia, United States
Virginia Mason Medical Center — Seattle, Washington, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Allgemeines Krankenhaus - Universitatskliniken Wein — Vienna, Austria

Full record on ClinicalTrials.gov

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