Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement
Phase 1
Terminated
- Conditions
- Healthy
- Interventions
- Other: Cleaning capsule
- 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.
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
- Arm && Interventions
Group Intervention Description Colon-targeted cleaning capsule Cleaning capsule -
- 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