Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT03223532
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .
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': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Prospective, Randomized, Open Label Trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Serious Adverse Events related to the Day 0 FRP', 'timeFrame': '8 weeks', 'description': 'Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of PrePex Day 0 FRP', 'timeFrame': '8 weeks', 'description': "Evaluating the PrePex Day 0 FRP acceptability to subjects and health care providers compared to the standard Day 7 FRP, by means of the following parameters:\n\n1. Evaluation of pain by the following parameters: Subject's subjective pain, tingling and discomfort\n2. Odour assessment while device is in situ by means of questionnaires on follow up visit 3 and on removal visit day.\n3. Subjects / health care providers satisfaction"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Circumcision']}, 'descriptionModule': {'briefSummary': 'A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.', 'detailedDescription': 'Study Objectives:\n\nTo compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP\n\nPlanned Subjects Population:\n\nOne hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects.\n\nStudy duration per subject will be up to 7 weeks and will include a total of 9 visits.\n\nStudy Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training Centre, Kisumu, Kenya'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '13 Years', 'genderBased': True, 'genderDescription': 'Uncircumcised males willing to undergo the non-surgical PrePex male circumcision procedure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages - 13 to 49 years\n* Uncircumcised\n* Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision\n* Willing to be circumcised\n* Legal guardian consent to the procedure for ages 13-18 years\n* Agrees to be circumcised by any of the study methods, Day0 FRP or Day7 FRP as will be determined randomly\n* Able to understand the study procedures and requirements\n* Agrees to abstain from sexual intercourse for 8 weeks after circumcision\n* Agrees to abstain from masturbation for at least 2 weeks after Removal\n* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 6 weeks post removal (7 weeks total)\n* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study\n\nExclusion Criteria:\n\n* Legal guardian withholds consent for ages 13-18 years\n* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision\n* Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias\n* Known bleeding / coagulation abnormality, uncontrolled diabetes\n* Subject that to the opinion of the investigator is not a good candidate\n* Subject does not agree to anonymous video and photographs of the procedure and follow up visits.'}, 'identificationModule': {'nctId': 'NCT03223532', 'briefTitle': 'Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .', 'organization': {'class': 'OTHER', 'fullName': 'Nyanza Reproductive Health Society'}, 'officialTitle': 'A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings', 'orgStudyIdInfo': {'id': 'VMMC005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PrePex Day 7 FRP', 'description': 'Standard PrePex procedure, 1 week after device placement foreskin and device are removed.\n\n\\*Subjects must be adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision', 'interventionNames': ['Device: PrePex Day 7 FRP']}, {'type': 'EXPERIMENTAL', 'label': 'PrePex Day 0 FRP', 'description': 'On the day of device placement the foreskin is removed, the device is removed 1 week later.', 'interventionNames': ['Device: PrePex Day 0 FRP']}], 'interventions': [{'name': 'PrePex Day 7 FRP', 'type': 'DEVICE', 'description': 'Standard PrePex procedure, foreskin and device are removed 1 week after device application.', 'armGroupLabels': ['PrePex Day 7 FRP']}, {'name': 'PrePex Day 0 FRP', 'type': 'DEVICE', 'description': 'Removal of the foreskin shortly after device application, the device is removed 1 week later', 'armGroupLabels': ['PrePex Day 0 FRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O. Box 1764', 'city': 'Kisumu', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Nyanza Reproductive Health Society', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Fredrick Otieno, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nyanza Reproductive Health Society'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nyanza Reproductive Health Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}