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NCT03241368 · ClinicalTrials.gov registry record · NA
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.
A NA study of Crohn Disease, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT03241368: Completed NA study of Crohn Disease, sponsored by Medtronic - MITG.
NCT03241368 is a NA study of Crohn Disease that has completed, run by Medtronic - MITG. The registered enrollment target is 187 participants, roughly in line with the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target. The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03241368, a NA study of Crohn Disease, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score
Conditions Studied
Interventions
- DEVICE Capsule Endoscopy
Study Locations (20)
Indiana
- Indiana University - Indianapolis
- Indianapolis Gastroenterology Research Foundation - Indianapolis
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- The Ohio State University Medical Center - Columbus
Alabama
- University of South Alabama - Mobile
Arizona
- Mayo Clinic (Scottsdale, AZ) - Scottsdale
Florida
- Encore Borland Groover Clinical Research - Jacksonville
Georgia
- Children's Center for Digestive Healthcare - Atlanta
Illinois
- Loyola University - Chicago - Maywood
Kansas
- University of Kansas - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2019-06-20 |
| Phase | NA |
What the finished NCT03241368 record still lists
NCT03241368 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target.
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention - of which Capsule Endoscopy is the first listed.
NCT03241368 names 20 study sites across 18 states, led by Indiana, Ohio, Alabama.
Frequently Asked Questions
What is clinical trial NCT03241368 about?
NCT03241368 is a clinical study titled "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.". 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 f...
What is the current status of trial NCT03241368?
This trial is currently completed. It is a NA study. The enrollment target is 187 participants. The study started on 2017-12-21. Estimated completion is 2019-06-20.
What conditions does trial NCT03241368 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT03241368?
The interventions under investigation include: Capsule Endoscopy (DEVICE).
Who is sponsoring clinical trial NCT03241368?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03241368 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03241368's enrollment target sits among peer trials
187 21st of 71 higher than 51 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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