Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Last updated: July 29, 2019
Sponsor: Medtronic - MITG
Overall Status: Completed

Phase

2/3

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT01185002
MA-111
  • Ages 50-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 providewritten informed consent.

Exclusion

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 wouldbe unlikely to lead to bowel obstruction based on the clinical judgment of theinvestigator

  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 thestudy

  7. Subject is expected to undergo MRI examination within 7 days after ingestion of thecapsule.

  8. Subject with any condition believed to have an increased risk for capsule retentionsuch as Crohn's disease, intestinal tumors, radiation enteritis, and incompletecolonoscopies 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 deviceinstructions.

  12. Women who are either pregnant or nursing at the time of screening, or are ofchild-bearing potential and do not practice medically acceptable methods ofcontraception.

  13. Subject suffers from life threatening conditions

  14. Subject currently participating in another clinical study

Study Design

Total Participants: 80
Study Start date:
July 01, 2010
Estimated Completion Date:
June 30, 2011

Study 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).

Connect with a study center

  • Alabama Digestive Disorders Center

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • Division of Gastroenterology Indiana University Medical Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Research Associates of New York

    New York, New York 10075
    United States

    Site Not Available

  • University of North Carolina Division of Digestive Disease

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina Division of Digestive Disease

    Chapel Hill,, North Carolina 27599
    United States

    Site Not Available

  • Digestive Care, Inc.

    Beavercreek, Ohio 45440
    United States

    Site Not Available

  • Franklin Gastroenterology

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Site Not Available

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