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

August 18, 2010
June 9, 2011
July 2010
June 2011   (final data collection date for primary outcome measure)
Capsule excretion rate [ Time Frame: 10 hours post capsule ingestion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01185002 on ClinicalTrials.gov Archive Site
Distribution of PillCam® COLON 2 excretion times [ Time Frame: Up to 12 hours and at least 12 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

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.

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).

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Colonoscopy
  • Endoscopy
  • 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.
  • 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
  • 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
  • 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.

    Intervention: Other: PillCam® COLON 2 procedure using 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

    Intervention: Other: PillCam® COLON 2 procedure using 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

    Intervention: Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01185002
MA-111
No
Hilla Debby / Director of Clinical Affaris, Given Imaging Ltd.
Given Imaging Ltd.
Not Provided
Principal Investigator: Douglas Rex, Prof. Division of Gastroenterology Indiana University Medical Center
Given Imaging Ltd.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP