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

NCT ID: NCT04755634

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-23

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Micropenis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

Hyaluronic Acid

Intervention Type DEVICE

Injectable

Interventions

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Hyaluronic Acid

Injectable

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shafer Clinic Fifth Avenue

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Shafer, MD

Role: PRINCIPAL_INVESTIGATOR

Shafer Clinic Fifth Avenue

Locations

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Shafer Clinic Fifth Avenue

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Director Clinical Studies

Role: CONTACT

12012802127

Facility Contacts

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Mussarrat Hussain

Role: primary

212-888-7770

Other Identifiers

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Pro00034295

Identifier Type: -

Identifier Source: org_study_id

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