A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

NCT04231422 | Unknown

• 1 other identifier: BRAND-003
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.

Conditions

Penile Elongation

Keywords

platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Stretched penile length

  Change in length of stretched, flaccid penile length

  baseline to six months

Secondary Outcomes (3)

• SHIM Score

  baseline to six months

• BDD-YBOCS

  baseline to six months

• Safety Measurement

  baseline to six months

Study Arms (1)

Treatment Group

Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.

Combination Product: Platelet-rich plasma

Interventions

Platelet-rich plasma COMBINATION_PRODUCT

12mL of platelet-rich plasma injected into cavernosal bodies bilaterally

Treatment Group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study participants comprised of men with a desire for penile elongation.

You may qualify if:

• Stretched penile length between 3.5 - 8.0 in
• Age 20-55 years of age
• Desire penile length elongation
• Willing to complete all aspects of combined treatment plan
• Able to measure erect penile length and mid-shaft girth at 1-month intervals
• Judged to be in good health based on medical history, physical exam, and laboratory profile
• Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

You may not qualify if:

• No prior surgical Peyronie's disease treatment
• No chordee with or without hypospadias
• No infiltration by benign or malignant mass
• No active STD
• No infiltration by an infectious agent such as lymphogranuloma venereum
• No uncontrolled psychiatric conditions
• No uncontrolled neurologic conditions
• No other uncontrolled medical conditions such as HTN or DM
• No history of spontaneous priapism
• Is unable to safely use the study devices as determined by the principal investigator
• No thrombosis of the dorsal penile artery or vein
• No known history of coagulation disorder
• No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
• Testosterone level lower than 500

Sponsors & Collaborators

• Judson Brandeis: lead

Study Sites (1)

BrandeisMD

San Ramon, California, 94583, United States

RECRUITING

Study Officials

• Judson Brandeis, MD

  BrandeisMD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judson Brandeis, MD

CONTACT

510-587-3000; Judson@BrandeisMD.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: November 12, 2019
• Primary Completion: May 12, 2021
• Study Completion: July 12, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)