Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

NCT ID: NCT01185002

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-06-30

Brief 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.

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).

Conditions

Colonoscopy; Endoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PillCam® COLON 2 procedure using MgC boosts

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

PillCam® COLON 2 procedure using Suprep boosts

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

PillCam® COLON 2 procedure using reduced dose of Suprep boosts

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Rex, Prof.

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology Indiana University Medical Center

Locations

Alabama Digestive Disorders Center

Huntsville, Alabama, United States

Division of Gastroenterology Indiana University Medical Center

Indianapolis, Indiana, United States

Research Associates of New York

New York, New York, United States

University of North Carolina Division of Digestive Disease

Chapel Hill, North Carolina, United States

Digestive Care, Inc.

Beavercreek, Ohio, United States

Franklin Gastroenterology

Franklin, Tennessee, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Countries

United States

Other Identifiers

MA-111

Identifier Type: -

Identifier Source: org_study_id