Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 1:16 PM
Study NCT ID:
NCT01370759
Status:
TERMINATED
Last Update Posted:
2019-07-31
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'whyStopped': 'Terminated due to sponsor desicioun', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cleansing grading', 'timeFrame': 'within 10 days'}], 'secondaryOutcomes': [{'measure': 'Distribution of time', 'timeFrame': 'within 10 days'}, {'measure': 'GI tract segment of capsule disintegration', 'timeFrame': 'within 10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bowel prep', 'PillCam'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.', 'detailedDescription': 'To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.\n\nThe study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject's age is between 23-75 years.\n* Subject is healthy.\n* Subject agrees to sign the Informed Consent Form\n\nExclusion Criteria:\n\n* Contraindication to capsule endoscopy\n* Contraindication or allergy to any of the products and materials used for bowel preparation\n* Subject is not able to provide written informed consent"}, 'identificationModule': {'nctId': 'NCT01370759', 'acronym': 'RD-400', 'briefTitle': 'Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study', 'orgStudyIdInfo': {'id': 'CTIL - RD-400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colon-targeted cleaning capsule', 'interventionNames': ['Other: Cleaning capsule']}], 'interventions': [{'name': 'Cleaning capsule', 'type': 'OTHER', 'otherNames': ['Active cleaning capsules'], 'description': 'Capsules containing the tested materials aimed to improve colon cleansing', 'armGroupLabels': ['Colon-targeted cleaning capsule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Ian Gralnek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}