Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
1 other identifier
interventional
80
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 18, 2010
CompletedFirst Posted
Study publicly available on registry
August 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 31, 2019
February 1, 2011
11 months
August 18, 2010
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Capsule excretion rate
10 hours post capsule ingestion
Secondary Outcomes (1)
Distribution of PillCam® COLON 2 excretion times
Up to 12 hours and at least 12 hours
Study Arms (3)
MgC boosts
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
Suprep boosts - Reduced dose
EXPERIMENTALSubjects 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
Interventions
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.
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
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
Eligibility Criteria
You may qualify if:
- Subject is between 50 - 75 years of age.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
You may not qualify if:
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has Diabetes type I.
- 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
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Subject has any allergy or other known contraindication to the medications used in the study
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- 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.
- Subject with gastrointestinal motility disorders
- Subject has known delayed gastric emptying
- Subject has any condition, which precludes compliance with study and/or device instructions.
- 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.
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (7)
Alabama Digestive Disorders Center
Huntsville, Alabama, 35802, United States
Division of Gastroenterology Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Research Associates of New York
New York, New York, 10075, United States
University of North Carolina Division of Digestive Disease
Chapel Hill, North Carolina, 27599, United States
Digestive Care, Inc.
Beavercreek, Ohio, 45440, United States
Franklin Gastroenterology
Franklin, Tennessee, 37067, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Rex, Prof.
Division of Gastroenterology Indiana University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2010
First Posted
August 19, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 31, 2019
Record last verified: 2011-02