Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

Completed · Not applicable

Conditions studied: Known Crohn Disease Subjects

In brief

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Key facts

Study ID

NCT01942720

Run by

Medtronic - MITG

People needed

74

Starts

2013-08-01

Expected to finish

2016-07-01

Last updated by the study team

2017-05-31

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject ages 2-75 years, inclusive
• Subjects with a diagnosis of known Crohn disease
• Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
• Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.
• Subject or parent agrees to sign consent form

You may not qualify if…

• The presence of any of the following will exclude a subject from study enrollment:
• Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
• Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
• Stricture seen on radiological exam.
• Indeterminate Colitis
• Ulcerative Colitis
• Antibiotic Associated Colitis
• Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment
• Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subjects with known or suspected delayed gastric emptying
• Subjects with known or suspected delayed Small bowel motility
• Subject has any allergy or other known contraindication to the medications used in the study.
• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.
• Unwillingness to use a medically accepted method of contraception throughout duration of study
• Concurrent participation in another clinical trial using any investigational drug or device.
• Subject has cardiac pacemaker or other implanted electromedical devices
• Subject suffers from a life threatening condition.
• Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
• Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Children's Center for Digestive Healthcare — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• Indiana Unveresity Hospital — Indianapolis, Indiana, United States
• Iowa Digestive Disease Center — Clive, Iowa, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Metropolitan Gastroenterology Group — Chevy Chase, Maryland, United States
• Digestive Health Center of Michigan — Michigan, Michigan, United States
• Atlantic Health System Morristown Memorial Pediatric GE — Morristown, New Jersey, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Dr. Romeo, Dayton Gastroenterology — Dayton, Ohio, United States
• Gastroenterology Associates of Tidewater — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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