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NCT01370759 Clinical Trial

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

Healthy Clinical Trial

— RD-400  

Official title:
Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01370759
Other study ID # CTIL - RD-400
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 2011
Est. completion date April 2014

Study information
Verified date April 2014
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Terminated
Enrollment 81
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Cleaning capsule
Capsules containing the tested materials aimed to improve colon cleansing

Locations
Country Name City State
Israel Rambam Medical center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cleansing grading within 10 days
Secondary Distribution of time within 10 days
Secondary GI tract segment of capsule disintegration within 10 days
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