Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-14 @ 8:05 PM
Study NCT ID:
NCT01185002
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2010-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2010-08-18', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capsule excretion rate', 'timeFrame': '10 hours post capsule ingestion'}], 'secondaryOutcomes': [{'measure': 'Distribution of PillCam® COLON 2 excretion times', 'timeFrame': 'Up to 12 hours and at least 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CE', 'colonoscopy', 'colon', 'Eligable for colon evaluation'], 'conditions': ['Colonoscopy', 'Endoscopy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is between 50 - 75 years of age.\n2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.\n\nExclusion Criteria:\n\n1. Subject has dysphagia or any swallowing disorder\n2. Subject has congestive heart failure\n3. Subject has Diabetes type I.\n4. 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\n5. Subject has a cardiac pacemaker or other implanted electro medical device.\n6. Subject has any allergy or other known contraindication to the medications used in the study\n7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.\n8. 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.\n9. Subject with gastrointestinal motility disorders\n10. Subject has known delayed gastric emptying\n11. Subject has any condition, which precludes compliance with study and/or device instructions.\n12. 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.\n13. Subject suffers from life threatening conditions\n14. Subject currently participating in another clinical study"}, 'identificationModule': {'nctId': 'NCT01185002', 'briefTitle': 'Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen', 'orgStudyIdInfo': {'id': 'MA-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MgC boosts', 'description': 'Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.\n\nIn this arm the subjects will be administered MgC boosts.', 'interventionNames': ['Other: PillCam® COLON 2 procedure using MgC boosts']}, {'type': 'EXPERIMENTAL', 'label': 'Suprep boosts', 'description': 'Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.\n\nIn this arm the subjects will be administered Suprep boosts', 'interventionNames': ['Other: PillCam® COLON 2 procedure using Suprep boosts']}, {'type': 'EXPERIMENTAL', 'label': 'Suprep boosts - Reduced dose', 'description': 'Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.\n\nIn this arm the subjects will be administered a reduced dose of Suprep boosts', 'interventionNames': ['Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts']}], 'interventions': [{'name': 'PillCam® COLON 2 procedure using MgC boosts', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['MgC boosts']}, {'name': 'PillCam® COLON 2 procedure using Suprep boosts', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Suprep boosts']}, {'name': 'PillCam® COLON 2 procedure using reduced dose of Suprep boosts', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Suprep boosts - Reduced dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35802', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Digestive Disorders Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Division of Gastroenterology Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Division of Digestive Disease', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45440', 'city': 'Beavercreek', 'state': 'Ohio', 'country': 'United States', 'facility': 'Digestive Care, Inc.', 'geoPoint': {'lat': 39.70923, 'lon': -84.06327}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Franklin Gastroenterology', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '23320', 'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gastroenterology Associates of Tidewater', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}], 'overallOfficials': [{'name': 'Douglas Rex, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenterology Indiana University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}