Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 5:04 AM
Study NCT ID:
NCT04755634
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2021-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536649', 'term': 'Penis agenesis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in penile width and girth', 'timeFrame': '1 year', 'description': 'Three-dimensional (3D) surface images taken by a digital stereophotogrammetry system at the baseline will be compared to the images taken at 1 year post-treatment follow up.'}], 'secondaryOutcomes': [{'measure': 'Duration of increase in penile width and girth', 'timeFrame': '1 year', 'description': 'For how long duration the treatment will produce a measurable difference in penile size.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Micropenis']}, 'descriptionModule': {'briefSummary': 'Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males,\n* 21 to 65 years of age,\n* Seeking enhancement of their penile width and girth.\n\nExclusion Criteria:\n\n* Patient with a history of psychological or psychiatric illness,\n* Congenital or acquired penile malformation,\n* Previous plastic surgery or non-invasive treatments of their penis,\n* Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.\n* Patients with a history of allergic reactions to hyaluronic acid derivatives\n* Individuals with penises measured less than 6 cm in length in the flaccid position\n* Individuals with penises greater than 12.5 cm in length in the flaccid position.\n* Individuals with uncircumcised penises'}, 'identificationModule': {'nctId': 'NCT04755634', 'briefTitle': 'Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement', 'organization': {'class': 'NETWORK', 'fullName': 'Shafer Clinic Fifth Avenue'}, 'officialTitle': 'Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement', 'orgStudyIdInfo': {'id': 'Pro00034295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'This is a prospective, single-arm, single-center study', 'interventionNames': ['Device: Hyaluronic Acid']}], 'interventions': [{'name': 'Hyaluronic Acid', 'type': 'DEVICE', 'description': 'Injectable', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mussarrat Hussain', 'role': 'CONTACT', 'email': 'mussarrathussain@gmail.com', 'phone': '212-888-7770'}], 'facility': 'Shafer Clinic Fifth Avenue', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Director Clinical Studies', 'role': 'CONTACT', 'email': 'mussarrathussain@gmail.com', 'phone': '12012802127'}], 'overallOfficials': [{'name': 'David Shafer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shafer Clinic Fifth Avenue'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shafer Clinic Fifth Avenue', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}