Clinical trial NCT01185002: Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
Official title: Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colonoscopy
Endoscopy
Keywords: CE
colonoscopy
colon
Eligable for colon evaluation
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Capsule excretion rate
timeFrame: 10 hours post capsule ingestion
Secondary outcomes:
measure: Distribution of PillCam® COLON 2 excretion times
timeFrame: Up to 12 hours and at least 12 hours
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Digestive Disorders Center
state: Alabama
city: Indianapolis
country: United States
facility: Division of Gastroenterology Indiana University Medical Center
state: Indiana
city: New York
country: United States
facility: Research Associates of New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Division of Digestive Disease
state: North Carolina
city: Beavercreek
country: United States
facility: Digestive Care, Inc.
state: Ohio
city: Franklin
country: United States
facility: Franklin Gastroenterology
state: Tennessee
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
Study officials:
affiliation: Division of Gastroenterology Indiana University Medical Center
name: Douglas Rex, Prof.
role: PRINCIPAL_INVESTIGATOR
References: