A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
NCT ID: NCT04231422
Last Updated: 2020-01-18
Study Results
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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UNKNOWN
30 participants
OBSERVATIONAL
2019-11-12
2021-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Group
Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.
Platelet-rich plasma
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
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
55 Years
MALE
Yes
Sponsors
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Judson Brandeis
INDUSTRY
Responsible Party
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Judson Brandeis
Principal 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRAND-003
Identifier Type: -
Identifier Source: org_study_id
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