NCT02481219

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients. Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.

Detailed description

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE. Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.

Conditions

• Colorectal Cancer Screening

Interventions

Type	Name	Description
DEVICE	PillCam® COLON 2 procedure-CONTROL
DRUG	Senna tablets
DRUG	PEG
DRUG	Metoclopramide
DRUG	Erythromycin
DRUG	SUPREP oral sulfate solution
DRUG	Bisacodyl
DRUG	SUPREP oral sulfate solution with Gastrografin

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2015-06-25
• Last updated: 2017-03-07
• Results posted: 2016-07-11

Locations

6 sites across 1 country: United States