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

NCT02481219 NA COMPLETED Results posted

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.

Details

Lead sponsor	Medtronic - MITG
Phase	NA
Status	COMPLETED
Enrolment	122
Start date	2015-05
Completion	2016-02

Conditions

• Colorectal Cancer Screening

Interventions

• PillCam® COLON 2 procedure-CONTROL
• Senna tablets
• PEG
• Metoclopramide
• Erythromycin
• SUPREP oral sulfate solution
• Bisacodyl
• SUPREP oral sulfate solution with Gastrografin

Primary outcomes

• Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) — Within two weeks of study procedure
  The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).

Countries

United States