Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement (RD-400)

July 29, 2019 updated by: Medtronic - MITG

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colon-targeted cleaning capsule
Other: Cleaning capsule
Capsules containing the tested materials aimed to improve colon cleansing
Other Names:
  • Active cleaning capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cleansing grading
Time Frame: within 10 days
within 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of time
Time Frame: within 10 days
within 10 days
GI tract segment of capsule disintegration
Time Frame: within 10 days
within 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Ian Gralnek, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTIL - RD-400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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