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A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04231422
Enrollment
30
Registered
2020-01-18
Start date
2019-11-12
Completion date
2021-07-12
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penile Elongation

Keywords

platelet-rich plasma

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.

Interventions

COMBINATION_PRODUCTPlatelet-rich plasma

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

Sponsors

Judson Brandeis
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Stretched penile length between 3.5 - 8.0 in 2. Age 20-55 years of age 3. Desire penile length elongation 4. Willing to complete all aspects of combined treatment plan 5. Able to measure erect penile length and mid-shaft girth at 1-month intervals 6. Judged to be in good health based on medical history, physical exam, and laboratory profile 7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

Exclusion criteria

1. No prior surgical Peyronie's disease treatment 2. No chordee with or without hypospadias 3. No infiltration by benign or malignant mass 4. No active STD 5. No infiltration by an infectious agent such as lymphogranuloma venereum 6. No uncontrolled psychiatric conditions 7. No uncontrolled neurologic conditions 8. No other uncontrolled medical conditions such as HTN or DM 9. No history of spontaneous priapism 10. Is unable to safely use the study devices as determined by the principal investigator 11. No thrombosis of the dorsal penile artery or vein 12. No known history of coagulation disorder 13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study 14. Testosterone level lower than 500

Design outcomes

Primary

MeasureTime frameDescription
Stretched penile lengthbaseline to six monthsChange in length of stretched, flaccid penile length

Secondary

MeasureTime frameDescription
SHIM Scorebaseline to six monthsChange in erectile function
BDD-YBOCSbaseline to six monthsChange in body dysmorphia scale
Safety Measurementbaseline to six monthsIncidence of adverse events and serious adverse events

Countries

United States

Contacts

Primary ContactJudson Brandeis, MD
Judson@BrandeisMD.com510-587-3000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026