Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01185002
First received: August 18, 2010
Last updated: June 9, 2011
Last verified: February 2011
  Purpose

The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.


Condition Intervention Phase
Colonoscopy
Endoscopy
Other: PillCam® COLON 2 procedure using MgC boosts
Other: PillCam® COLON 2 procedure using Suprep boosts
Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Capsule excretion rate [ Time Frame: 10 hours post capsule ingestion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of PillCam® COLON 2 excretion times [ Time Frame: Up to 12 hours and at least 12 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MgC boosts

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.

In this arm the subjects will be administered MgC boosts.

Other: PillCam® COLON 2 procedure using MgC boosts
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.
Experimental: Suprep boosts

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.

In this arm the subjects will be administered Suprep boosts

Other: PillCam® COLON 2 procedure using Suprep boosts
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts
Experimental: Suprep boosts - Reduced dose

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.

In this arm the subjects will be administered a reduced dose of Suprep boosts

Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts

Detailed Description:

Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is between 50 - 75 years of age.
  2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

  1. Subject has dysphagia or any swallowing disorder
  2. Subject has congestive heart failure
  3. Subject has Diabetes type I.
  4. Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
  5. Subject has a cardiac pacemaker or other implanted electro medical device.
  6. Subject has any allergy or other known contraindication to the medications used in the study
  7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  8. Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
  9. Subject with gastrointestinal motility disorders
  10. Subject has known delayed gastric emptying
  11. Subject has any condition, which precludes compliance with study and/or device instructions.
  12. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  13. Subject suffers from life threatening conditions
  14. Subject currently participating in another clinical study
  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: NCT01185002

Locations
United States, Alabama
Alabama Digestive Disorders Center
Huntsville, Alabama, United States, 35802
United States, Indiana
Division of Gastroenterology Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, New York
Research Associates of New York
New York, New York, United States, 10075
United States, North Carolina
University of North Carolina Division of Digestive Disease
Chapel Hill,, North Carolina, United States, 27599
United States, Ohio
Digestive Care, Inc.
Beavercreek, Ohio, United States, 45440
United States, Tennessee
Franklin Gastroenterology
Franklin, Tennessee, United States, 37067
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Douglas Rex, Prof. Division of Gastroenterology Indiana University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Hilla Debby / Director of Clinical Affaris, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01185002     History of Changes
Other Study ID Numbers: MA-111
Study First Received: August 18, 2010
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
CE
colonoscopy
colon
Eligable for colon evaluation

ClinicalTrials.gov processed this record on October 23, 2014