Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT05099432
Status:
RECRUITING
Last Update Posted:
2021-11-15
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The CARMA Technique Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-14', 'size': 217638, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-18T06:22', 'hasProtocol': True}, {'date': '2021-10-14', 'size': 328863, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-10-18T06:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of achieving a clear resection margin using the CARMA technique', 'timeFrame': 'Established during index procedure'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of the CARMA technique for residual polyp detection', 'timeFrame': 'Established during index procedure'}, {'measure': 'Frequency of residual polyp without CARMA assessment', 'timeFrame': 'Established during index procedure'}, {'measure': 'Incomplete resection rate with use of CARMA technique', 'timeFrame': 'Established during index procedure'}, {'measure': 'Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare', 'timeFrame': 'Established during index procedure'}, {'measure': 'Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare', 'timeFrame': 'Established during index procedure'}, {'measure': 'Residual polyp rate after CARMA technique with hot snare', 'timeFrame': 'Established during index procedure'}, {'measure': 'Residual polyp rate after CARMA technique with cold snare', 'timeFrame': 'Established during index procedure'}, {'measure': 'Time required for application of the CARMA technique with < 10mm', 'timeFrame': 'Established during index procedure'}, {'measure': 'Time required for application of the CARMA technique with > 10mm', 'timeFrame': 'Established during index procedure'}, {'measure': 'Polyp recurrence rate for < 10mm polyps', 'timeFrame': 'Established during surveillance procedure (following national guidelines - between 6 months to 5 years)'}, {'measure': 'Polyp recurrence rate for > 10mm polyps', 'timeFrame': 'Established during surveillance procedure (following national guidelines - between 6 months to 5 years)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyp', 'Colonic Sessile Serrated Lesion']}, 'descriptionModule': {'briefSummary': 'Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problemÍž this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with colonic polyps will be considered following below criteria\n\nInclusion Criteria:\n\n\\- any polypectomy (though only a maximum of two polyps from one individual participant)\n\nExclusion Criteria:\n\n* polyps less than 10mm which were resected under endoscopic view with a definite \\> 1mm clear margin\n* scar site recurrence polyps\n* polyps with endoscopic evidence of invasion\n* pedunculated polyps\n* pseudopolyps\n* participants who will not be available for follow up endoscopy'}, 'identificationModule': {'nctId': 'NCT05099432', 'briefTitle': 'The CARMA Technique Study', 'organization': {'class': 'OTHER', 'fullName': 'Princess Alexandra Hospital, Brisbane, Australia'}, 'officialTitle': 'The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a "Novel" Approach to Reduce Polyp Recurrence', 'orgStudyIdInfo': {'id': '75076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARMA Technique', 'description': 'All included participants undergo polyp resection using standard of care polypectomy techniques, followed by the CARMA technique', 'interventionNames': ['Procedure: CARMA technique']}], 'interventions': [{'name': 'CARMA technique', 'type': 'PROCEDURE', 'description': "Once standard polyp resection and assessment of the polypectomy site without magnification is completed, the CARMA technique will be applied. This will involve an assessment of the entire polypectomy margin using cap assisted magnification endoscopy with the ability to also use NBI (at the endoscopist's discretion) and documentation of any residual polyp noted.", 'armGroupLabels': ['CARMA Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Alexander Huelsen, MD', 'role': 'CONTACT', 'email': 'alexander.huelsenkatz@health.qld.gov.au', 'phone': '+61 7 3176 2111'}, {'name': 'Alexander Huelsen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zaki Hamarneh', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Prabha Selvanathan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Borowsky', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Cooper', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}], 'centralContacts': [{'name': 'Alexander Huelsen, MD', 'role': 'CONTACT', 'email': 'alexander.huelsenkatz@health.qld.gov.au', 'phone': '+61 7 3176 2111'}], 'overallOfficials': [{'name': 'Alexander Huelsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Alexandra Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Alexandra Hospital, Brisbane, Australia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Gastroenterologist, Principal Investigator', 'investigatorFullName': 'Alexander Huelsen', 'investigatorAffiliation': 'Princess Alexandra Hospital, Brisbane, Australia'}}}}