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

Phase 1TerminatedNCT01370759

Medtronic - MITG81 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Cleaning capsuleOTHER

Capsules containing the tested materials aimed to improve colon cleansing

Eligibility

Sex: ALLMin age: 23 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rambam Medical center

Haifa, Israel

Outcomes

Primary Outcomes

Cleansing grading

Time frame: within 10 days

Secondary Outcomes

Distribution of time

Time frame: within 10 days

GI tract segment of capsule disintegration

Time frame: within 10 days

Data from ClinicalTrials.gov

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