Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

July 29, 2019 updated by: Medtronic - MITG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Alabama Digestive Disorders Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Division of Gastroenterology Indiana University Medical Center
    • New York
      • New York, New York, United States, 10075
        • Research Associates of New York
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Division of Digestive Disease
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Digestive Care, Inc.
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Franklin Gastroenterology
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Capsule excretion rate
Time Frame: 10 hours post capsule ingestion
10 hours post capsule ingestion

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of PillCam® COLON 2 excretion times
Time Frame: Up to 12 hours and at least 12 hours
Up to 12 hours and at least 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Douglas Rex, Prof., Division of Gastroenterology Indiana University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (ESTIMATE)

August 19, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MA-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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