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

NCT04755634 | Completed Results FDA Device

• 1 other identifier: Pro00034295
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Micropenis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Penile Shaft Girth at 1 Year

  Penile Shaft Girth was measured in centimeters at baseline and at the1-year post-treatment follow-up. Change from baseline was calculated as the penile shaft girth at the 1-year follow-up minus the penile shaft girth at baseline. Positive values indicate an increase in penile shaft girth, and negative values indicate a decrease.

  Baseline and 1-year post-treatment follow-up

Study Arms (1)

Single Arm

EXPERIMENTAL

This is a prospective, single-arm, single-center study

Device: Hyaluronic Acid

Interventions

Hyaluronic Acid DEVICE

Injectable

Single Arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males,
• to 65 years of age,
• Seeking enhancement of their penile width and girth.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shafer Clinic Fifth Avenue: lead

Study Sites (1)

Shafer Clinic Fifth Avenue

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Penis agenesis

Results Point of Contact

• Title: Director Clinical Studies
• Organization: Shafer Clinic Fifth Avenue

mussarrathussain@gmail.com

201 280 2127

Study Officials

• David Shafer, MD

  Shafer Clinic Fifth Avenue

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: April 23, 2021
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: August 18, 2026
• Results First Posted: August 18, 2026

Record last verified: 2026-07

Locations

US (1)