Study on safety and efficacy of Lipen-D on glans penis augmentation

Single-arm, single-blind, two center, 24 week design clinical study to evaluate the safety and efficacy of Lipen-D for glans penis augmentation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002066

Enrollment

Registered

2016-09-20

Start date

2013-08-13

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 : An experienced surgeon performed the procedure at each institute. The procedure was carried out in an office setting with the subject in the supine position. A penile block was induce

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - healthy men, aged 20 or over - men with small penis syndrome - during the study period, subject will not received any treatments associated with penile augmentation - subject will agree with investigator's decision - subject will sign an informed consent form

Exclusion criteria

Exclusion criteria: - any history of psychological or psychiatric illness, - congenital or acquired penile malformation including severe phimosis, - previous penile augmentation history, - any chronic major systemic disease including diabetes and coagulopathy

Design outcomes

Primary

Measure	Time frame
an increase in glans surface area of 20% 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

Outcome results