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

August 18, 2022 updated by: Shafer Clinic Fifth Avenue
Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in penile width and girth
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shafer Clinic Fifth Avenue

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00034295

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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