Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Colonoscopy Clinical Trial

Official title:

Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185002
• Other study ID #: MA-111
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Endoscopy

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
United States	Digestive Care, Inc.	Beavercreek	Ohio
United States	University of North Carolina Division of Digestive Disease	Chapel Hill	North Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Franklin Gastroenterology	Franklin	Tennessee
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsule excretion rate		10 hours post capsule ingestion
Secondary	Distribution of PillCam® COLON 2 excretion times		Up to 12 hours and at least 12 hours

External Links

•   Given Imaging Website