Shafer Width and Girth: The Use of Injectable Fillers for... | NCT04755634

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

NCT04755634

Sponsor

Shafer Clinic Fifth Avenue

Status

Completed

Last Update Posted

May 22, 2026Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Micropenis

Interventions

Hyaluronic Acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2021Actual

Primary Completion Date

Jun 27, 2024Actual

Completion Date

Jun 27, 2024Actual

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 12, 2021

First Posted Date

Feb 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	This is a prospective, single-arm, single-center study	Device: Hyaluronic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic Acid	Device	Injectable	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Duration of increase in penile width and girth	For how long duration the treatment will produce a measurable difference in penile size.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Shafer, MD	Shafer Clinic Fifth Avenue	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shafer Clinic Fifth Avenue		New York	New York	10017	United States

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 25, 2026

Condition Browse Module

MeSH Terms

ID	Term
C536649	Penis agenesis

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided