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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04755634
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Shafer Clinic Fifth Avenue

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

Condition or disease Intervention/treatment Phase
Micropenis Device: Hyaluronic Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755634


Contacts
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Contact: Director Clinical Studies 12012802127 mussarrathussain@gmail.com

Locations
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United States, New York
Shafer Clinic Fifth Avenue Recruiting
New York, New York, United States, 10017
Contact: Mussarrat Hussain    212-888-7770    mussarrathussain@gmail.com   
Sponsors and Collaborators
Shafer Clinic Fifth Avenue
Investigators
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Principal Investigator: David Shafer, MD Shafer Clinic Fifth Avenue
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Responsible Party: Shafer Clinic Fifth Avenue
ClinicalTrials.gov Identifier: NCT04755634    
Other Study ID Numbers: Pro00034295
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents