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

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ClinicalTrials.gov Identifier: NCT01370759
Recruitment Status : Terminated (Terminated due to sponsor desicioun)
First Posted : June 10, 2011
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Other: Cleaning capsule Phase 1

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  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study
Study Start Date : September 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Colon-targeted cleaning capsule Other: Cleaning capsule
Capsules containing the tested materials aimed to improve colon cleansing
Other Name: Active cleaning capsules



Primary Outcome Measures :
  1. Cleansing grading [ Time Frame: within 10 days ]

Secondary Outcome Measures :
  1. Distribution of time [ Time Frame: within 10 days ]
  2. GI tract segment of capsule disintegration [ Time Frame: within 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370759


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

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01370759     History of Changes
Other Study ID Numbers: CTIL - RD-400
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Keywords provided by Given Imaging Ltd.:
bowel prep
PillCam