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

NCT ID: NCT01370759

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Colon-targeted cleaning capsule

Group Type EXPERIMENTAL

Cleaning capsule

Intervention Type OTHER

Capsules containing the tested materials aimed to improve colon cleansing

Interventions

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Cleaning capsule

Capsules containing the tested materials aimed to improve colon cleansing

Intervention Type OTHER

Other Intervention Names

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Active cleaning capsules

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Gralnek, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Medical center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CTIL - RD-400

Identifier Type: -

Identifier Source: org_study_id

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