Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT01800656
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-27', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-02-27', 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-polypectomy bleeding', 'timeFrame': '24h-15 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Polyp']}, 'descriptionModule': {'briefSummary': 'The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2) safety and feasibility of endoloop assisted snare polypectomy in patients with long-term antiplatelet therapy; 3) safety and feasibility of so called "ligate and let go" approach in patients with long-term antiplatelet therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pedunculated colorectal polyps\n* larger than 2cm in diameter\n* long-term antiplatelet therapy\n\nExclusion Criteria:\n\n* presence of intraepithelial'}, 'identificationModule': {'nctId': 'NCT01800656', 'briefTitle': 'Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Danilo I Cetinje'}, 'officialTitle': 'Endoloop-assisted Colorectal Polypectomy or "Ligate and Let go" in Patients With Long-term Antiplatelet Therapy', 'orgStudyIdInfo': {'id': 'ENDL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ligate and let go', 'description': 'Subjects are submitted to endoloop-assisted "ligate and let go" colorectal polypectomy.', 'interventionNames': ['Procedure: Endoloop-assisted "ligate and let go" colorectal polypectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Snare polypectomy', 'description': 'Subjects are submitted to endoloop-assisted snare colorectal polypectomy', 'interventionNames': ['Procedure: Endoloop-assisted snare colorectal polypectomy']}], 'interventions': [{'name': 'Endoloop-assisted "ligate and let go" colorectal polypectomy', 'type': 'PROCEDURE', 'description': 'The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.', 'armGroupLabels': ['Ligate and let go']}, {'name': 'Endoloop-assisted snare colorectal polypectomy', 'type': 'PROCEDURE', 'description': 'The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.', 'armGroupLabels': ['Snare polypectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Milutin Bulajic, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Danilo I Cetinje'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Milutin Bulajic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dr Milutin Bulajic', 'investigatorAffiliation': 'Hospital Danilo I Cetinje'}}}}