A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

NCT ID: NCT04231422

Last Updated: 2020-01-18

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-12

Study Completion Date

2021-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Penile Elongation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group

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

Platelet-rich plasma

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Platelet-rich plasma

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Judson Brandeis

INDUSTRY

Sponsor Role lead

Responsible Party

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Judson Brandeis

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Judson Brandeis, MD

Role: PRINCIPAL_INVESTIGATOR

BrandeisMD

Locations

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BrandeisMD

San Ramon, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Judson Brandeis, MD

Role: CONTACT

510-587-3000

Facility Contacts

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Judson Brandeis, MD

Role: primary

510-587-3000

Other Identifiers

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BRAND-003

Identifier Type: -

Identifier Source: org_study_id

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