Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
This study has been completed.
Sponsor:
Given Imaging Ltd.
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01185002
First received: August 18, 2010
Last updated: June 9, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy Endoscopy |
Other: PillCam® COLON 2 procedure using MgC boosts Other: PillCam® COLON 2 procedure using Suprep boosts Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen |
Resource links provided by NLM:
Further study details as provided by Given Imaging Ltd.:
Primary Outcome Measures:
- Capsule excretion rate [ Time Frame: 10 hours post capsule ingestion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Distribution of PillCam® COLON 2 excretion times [ Time Frame: Up to 12 hours and at least 12 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
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.
|
|
Experimental: 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 |
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
|
|
Experimental: 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 |
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
|
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| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185002
Locations
| United States, Alabama | |
| Alabama Digestive Disorders Center | |
| Huntsville, Alabama, United States, 35802 | |
| United States, Indiana | |
| Division of Gastroenterology Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New York | |
| Research Associates of New York | |
| New York, New York, United States, 10075 | |
| United States, North Carolina | |
| University of North Carolina Division of Digestive Disease | |
| Chapel Hill,, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Digestive Care, Inc. | |
| Beavercreek, Ohio, United States, 45440 | |
| United States, Tennessee | |
| Franklin Gastroenterology | |
| Franklin, Tennessee, United States, 37067 | |
| United States, Virginia | |
| Gastroenterology Associates of Tidewater | |
| Chesapeake, Virginia, United States, 23320 | |
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
| Principal Investigator: | Douglas Rex, Prof. | Division of Gastroenterology Indiana University Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hilla Debby / Director of Clinical Affaris, Given Imaging Ltd. |
| ClinicalTrials.gov Identifier: | NCT01185002 History of Changes |
| Other Study ID Numbers: | MA-111 |
| Study First Received: | August 18, 2010 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Given Imaging Ltd.:
|
CE colonoscopy colon Eligable for colon evaluation |
ClinicalTrials.gov processed this record on May 16, 2013