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NCT01631435 · ClinicalTrials.gov registry record · Phase 1
PillCam® Platform With the PillCam Crohn's Disease Capsule
A Phase 1 study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01631435: Completed Phase 1 study, sponsored by Medtronic - MITG.
NCT01631435 is a Phase 1 study that has completed, run by Medtronic - MITG. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01631435, a Phase 1 study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Primary Outcome
the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy. The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy. Each patient was classified as follows: * Active Crohn's disease is likely * Active Crohn's disease is NOT likely "Active Crohn's disease
Interventions
- OTHER Pillcam colon capsule and PillCam™ Prep Procedure
- DEVICE Ileocolonoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01631435 record still lists
NCT01631435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Pillcam colon capsule and PillCam™ Prep Procedure is the first listed.
NCT01631435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01631435 about?
NCT01631435 is a clinical study titled "PillCam® Platform With the PillCam Crohn's Disease Capsule". This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
What is the current status of trial NCT01631435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2012-06. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01631435?
The interventions under investigation include: Pillcam colon capsule and PillCam™ Prep Procedure (OTHER), Ileocolonoscopy (DEVICE).
Who is sponsoring clinical trial NCT01631435?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01631435's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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