Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-02 @ 6:43 PM
Study NCT ID:
NCT01998360
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014014', 'term': 'Tissue Adhesives'}], 'ancestors': [{'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pmillard@mac.com', 'phone': '2078663503', 'title': 'Peter S. Millard, MD, PhD', 'organization': 'University of New England'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive', 'otherNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.', 'otherNumAtRisk': 50, 'otherNumAffected': 9, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post-op bleeding or hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-op infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraoperative Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'OG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '10.0'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '27.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour', 'description': 'The number of minutes required to perform the surgical procedure', 'unitOfMeasure': 'Min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'OG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Bleeding, hematoma, infection and other rare adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'OG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '1.5'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During procedure (up to 1 hour)', 'description': 'Number of ml of blood lost during the procedure, as assessed by the surgeon', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'OG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The number of participants with complete epithelialization (completely healed) at 4 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cosmetic Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'OG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}], 'classes': [{'title': 'Regular', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Irregular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Scalloped', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Regular: scar line straight without any irregularity\n\nIrregular: Some irregularity to scar line\n\nScalloped: wavy appearane to scar line', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'FG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive\n\nUnicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive'}, {'id': 'BG001', 'title': 'Surgical Control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method\n\nSurgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2013-10-11', 'resultsFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-11-23', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-27', 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Duration', 'timeFrame': '1 hour', 'description': 'The number of minutes required to perform the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '1 month', 'description': 'Bleeding, hematoma, infection and other rare adverse events'}, {'measure': 'Blood Loss', 'timeFrame': 'During procedure (up to 1 hour)', 'description': 'Number of ml of blood lost during the procedure, as assessed by the surgeon'}, {'measure': 'Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks', 'timeFrame': '1 month', 'description': 'The number of participants with complete epithelialization (completely healed) at 4 weeks'}, {'measure': 'Cosmetic Result', 'timeFrame': '6 weeks', 'description': 'Regular: scar line straight without any irregularity\n\nIrregular: Some irregularity to scar line\n\nScalloped: wavy appearane to scar line'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circumcision', 'Voluntary medical male circumcision', 'Minimally-invasive', 'HIV prevention'], 'conditions': ['Circumcision']}, 'descriptionModule': {'briefSummary': 'This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.', 'detailedDescription': 'Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.\n\nAccording to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."\n\nThis quasi-experimental compares the open surgical technique to an alternative minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The controls come from a separate randomized controlled trial (Unicirc 001) that was conducted just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy men at least 18 years of age requesting circumcision\n\nNo anatomical penile abnormalities or infections\n\nAble to provide informed consent to participate\n\nWilling to participate in follow-up visits -\n\nExclusion Criteria:\n\nCurrent illness\n\nPenile abnormality or infection which contraindicates or would complicate circumcision\n\nHistory of bleeding disorder\n\nPast reaction to local anesthetic\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01998360', 'briefTitle': 'Rapid, Minimally-invasive Voluntary Adult Male Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'Simunye Primary Health Care'}, 'officialTitle': 'Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study', 'orgStudyIdInfo': {'id': 'Unicirc 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unicirc with tissue adhesive', 'description': 'Excision of foreskin with Unicirc device and sealing wound with tissue adhesive', 'interventionNames': ['Procedure: Unicirc with tissue adhesive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical control', 'description': 'Surgical circumcision using forceps guided, dorsal slit, or sleeve method', 'interventionNames': ['Procedure: Surgical Control']}], 'interventions': [{'name': 'Surgical Control', 'type': 'PROCEDURE', 'description': 'The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.', 'armGroupLabels': ['Surgical control']}, {'name': 'Unicirc with tissue adhesive', 'type': 'PROCEDURE', 'description': 'Excision of foreskin with Unicirc device and wound sealing with tissue adhesive', 'armGroupLabels': ['Unicirc with tissue adhesive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mitchells Plain', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Simunye Primary Healthcare', 'geoPoint': {'lat': -34.05341, 'lon': 18.62365}}], 'overallOfficials': [{'name': 'Norman Goldstuck, MB ChB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Simunye Primary Health Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simunye Primary Health Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Peter Millard', 'investigatorAffiliation': 'Simunye Primary Health Care'}}}}