NCT04755634

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

February 10, 2021

Last Update Submit

May 20, 2026

Conditions

Micropenis

Outcome Measures

Primary Outcomes (1)

  • Increase in penile width and girth

    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.

    1 year

Secondary Outcomes (1)

  • Duration of increase in penile width and girth

    1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Device: Hyaluronic Acid

Interventions

Hyaluronic AcidDEVICE

Injectable

Single Arm

Eligibility Criteria

Age21 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shafer Clinic Fifth Avenue

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Penis agenesis

Study Officials

  • David Shafer, MD

    Shafer Clinic Fifth Avenue

    PRINCIPAL INVESTIGATOR

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

May 22, 2026

Record last verified: 2026-05

Locations

US(1)