Trials / Completed
CompletedNCT01269372
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy. This study will also use to evaluate the administrative feasibility and data management of study design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PillCam Colon 2 | Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon. |
| DEVICE | Colonoscopy | The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2011-01-04
- Last updated
- 2020-10-01
- Results posted
- 2020-10-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01269372. Inclusion in this directory is not an endorsement.