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NCT01087528 · ClinicalTrials.gov registry record · NA
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
A NA study of Colonic Diseases and Bowel Diseases, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
- 4
- Study locations
NCT01087528: Completed NA study of Colonic Diseases and Bowel Diseases, sponsored by Medtronic - MITG.
NCT01087528 is a NA study of Colonic Diseases and Bowel Diseases that has completed, run by Medtronic - MITG. The registered enrollment target is 51 participants, below the 283-participant average among 6 other Colonic Diseases trials with a reported enrollment target (82% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087528, a NA study of Colonic Diseases and Bowel Diseases, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
- 4
- Study locations
Study Summary
To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
Primary Outcome
The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
Conditions Studied
Interventions
- DEVICE PillCam™ (Capsule Endoscopy) Colon 2 capsule
Study Locations (4)
Indiana
- Indiana University Medical Center - Indianapolis
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Digestive Care, Inc. - Beavercreek
Virginia
- Gastroenterology Associates of Tidewater - Chesapeake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-05 |
| Phase | NA |
What the finished NCT01087528 record still lists
NCT01087528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 283-participant average among 6 other Colonic Diseases trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Colonic Diseases appearing as the primary indexed condition, and to 1 intervention - of which PillCam™ (Capsule Endoscopy) Colon 2 capsule is the first listed.
NCT01087528 reports a single indexed study location in Indiana, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT01087528 about?
NCT01087528 is a clinical study titled "Evaluation of PillCam™ Colon 2 in Visualization of the Colon". To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
What is the current status of trial NCT01087528?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2009-07. Estimated completion is 2010-05.
What conditions does trial NCT01087528 study?
This clinical trial studies the following conditions: Colonic Diseases, Bowel Diseases.
What interventions are being tested in trial NCT01087528?
The interventions under investigation include: PillCam™ (Capsule Endoscopy) Colon 2 capsule (DEVICE).
Who is sponsoring clinical trial NCT01087528?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01087528 being conducted?
This trial has 4 study locations across Indiana, North Carolina, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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