Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

• Sponsor: Shafer Clinic Fifth Avenue (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04755634
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.

Condition or Disease	Intervention/Treatment	Phase
Micropenis	Device: Hyaluronic Acid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
• Actual Study Start Date: Apr 23, 2021
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm This is a prospective, single-arm, single-center study	Device: Hyaluronic Acid; Injectable

Outcome Measures

Primary Outcome Measures

1. Increase in penile width and girth [1 year]

   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.

Secondary Outcome Measures

1. Duration of increase in penile width and girth [1 year]

   For how long duration the treatment will produce a measurable difference in penile size.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy males,

• 21 to 65 years of age,

• Seeking enhancement of their penile width and girth.

Exclusion Criteria:

• Patient with a history of psychological or psychiatric illness,

• Congenital or acquired penile malformation,

• Previous plastic surgery or non-invasive treatments of their penis,

• Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.

• Patients with a history of allergic reactions to hyaluronic acid derivatives

• Individuals with penises measured less than 6 cm in length in the flaccid position

• Individuals with penises greater than 12.5 cm in length in the flaccid position.

• Individuals with uncircumcised penises

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shafer Clinic Fifth Avenue	New York	New York	United States	10017

Sponsors and Collaborators

• Shafer Clinic Fifth Avenue

Investigators

• Principal Investigator: David Shafer, MD, Shafer Clinic Fifth Avenue

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shafer Clinic Fifth Avenue
• ClinicalTrials.gov Identifier: NCT04755634
• Other Study ID Numbers: Pro00034295
• First Posted: Feb 16, 2021
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

No Results Posted as of Aug 22, 2022