Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Phase 2

Completed

• Conditions: Endoscopy; Colonoscopy
• Interventions: Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts; Other: PillCam® COLON 2 procedure using MgC boosts; Other: PillCam® COLON 2 procedure using Suprep boosts

• Registration Number: NCT01185002
• Lead Sponsor: Medtronic - MITG

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).

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Status Verified: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Suprep boosts - Reduced dose	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. In this arm the subjects will be administered a reduced dose of Suprep boosts
MgC boosts	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. In this arm the subjects will be administered MgC boosts.
Suprep boosts	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. In this arm the subjects will be administered Suprep boosts

Primary Outcome Measures

Name	Time	Method
Capsule excretion rate	10 hours post capsule ingestion

Secondary Outcome Measures

Name	Time	Method
Distribution of PillCam® COLON 2 excretion times	Up to 12 hours and at least 12 hours

Trial Locations

Locations (7)

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

Gastroenterology Associates of Tidewater; 🇺🇸 Chesapeake, Virginia, United States

Franklin Gastroenterology; 🇺🇸 Franklin, Tennessee, United States