Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement (RD-400)
The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study|
- Cleansing grading [ Time Frame: within 10 days ] [ Designated as safety issue: No ]
- Distribution of time [ Time Frame: within 10 days ] [ Designated as safety issue: No ]
- GI tract segment of capsule disintegration [ Time Frame: within 10 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Experimental: Colon-targeted cleaning capsule||
Other: Cleaning capsule
Capsules containing the tested materials aimed to improve colon cleansing
Other Name: Active cleaning capsules
To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.
The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370759
|Rambam Medical center|
|Principal Investigator:||Ian Gralnek, MD||Rambam Health Care Campus|