Augmentative effects of PoweFill

A Multi-center, Open, Single-arm design Clinical study to Evaluate the Efficacy and Safety of PowerFill for Penile Enhancement

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001827

Enrollment

Registered

2016-02-23

Start date

2012-08-22

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : The PLA filler used in our study (PowerFill®

REGEN Biotech, Inc., Seoul, Korea) is a newly developed filler for soft tissue augmentation. The filler consists of 10 g of 50 µm microparticles suspended in 3 mL of 3% carboxymethylcellulose and meth

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) healthy men, aged 20 to 65 (2) men with small penis syndrome (3) during the study period, subject will not received any treatments associated with penile augmentation (4) after 1month, subject can perform the sexual intercourse (5) subject will agree with investigator's decision (6) subject will sign an informed consent form

Exclusion criteria

Exclusion criteria: (1) any history of psychological or psychiatric illness, (2) congenital or acquired penile malformation including severe phimosis, (3) previous PA history, (4) any chronic major systemic disease including diabetes and coagulopathy

Design outcomes

Primary

Measure	Time frame
increase in penile girth by 1.2cm or more	—

Secondary

Measure	Time frame
subject satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactWon Ki Lee

Hallym University Medical Center- Chuncheon

rheewk@hanmail.net+82-33-240-5161

Outcome results