NCT01185002

Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.

Detailed description

Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).

Conditions

• Colonoscopy
• Endoscopy

Interventions

Type	Name	Description
OTHER	PillCam® COLON 2 procedure using MgC boosts	Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.
OTHER	PillCam® COLON 2 procedure using Suprep boosts	Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts
OTHER	PillCam® COLON 2 procedure using reduced dose of Suprep boosts	Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-08-19
• Last updated: 2019-07-31

Locations

7 sites across 1 country: United States