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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01370759
First received: June 9, 2011
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Other: Cleaning capsule
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Cleansing grading [ Time Frame: within 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of time [ Time Frame: within 10 days ] [ Designated as safety issue: No ]
  • GI tract segment of capsule disintegration [ Time Frame: within 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colon-targeted cleaning capsule Other: Cleaning capsule
Capsules containing the tested materials aimed to improve colon cleansing
Other Name: Active cleaning capsules

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.

  Eligibility

Ages Eligible for Study:   23 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370759

Locations
Israel
Rambam Medical center
Haifa, Israel
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Ian Gralnek, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01370759     History of Changes
Other Study ID Numbers: CTIL - RD-400
Study First Received: June 9, 2011
Last Updated: October 11, 2012
Health Authority: Israel: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Given Imaging Ltd.:
bowel prep
PillCam

ClinicalTrials.gov processed this record on May 16, 2013