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

This study has been terminated.
(Terminated due to sponsor desicioun)
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01370759
First received: June 9, 2011
Last updated: April 9, 2014
Last verified: April 2014
  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 ]

Enrollment: 81
Study Start Date: September 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 9, 2014
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 July 22, 2014