Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement

Phase 1

Terminated

• Conditions: Healthy

• Registration Number: NCT01370759
• Lead Sponsor: Medtronic - MITG

Brief Summary

The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Study Start: 2011-09
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Subject's age is between 23-75 years.
• Subject is healthy.
• Subject agrees to sign the Informed Consent Form

Exclusion Criteria

• Contraindication to capsule endoscopy
• Contraindication or allergy to any of the products and materials used for bowel preparation
• Subject is not able to provide written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cleansing grading	within 10 days

Secondary Outcome Measures

Name	Time	Method
Distribution of time	within 10 days
GI tract segment of capsule disintegration	within 10 days

Trial Locations

Locations (1)

Rambam Medical center; 🇮🇱 Haifa, Israel