Status:
COMPLETED
Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
Lead Sponsor:
Medy-Tox
Conditions:
Penile Enhancement
Eligibility:
MALE
19-65 years
Brief Summary
This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement. The pivotal study of Potenfill has already been completed and this observational stu...
Eligibility Criteria
Inclusion
- Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.
Exclusion
- Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation.
- Subjects deemed as ineligible to participate by the investigator
Key Trial Info
Start Date :
April 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04496427
Start Date
April 10 2019
End Date
December 11 2019
Last Update
August 3 2020
Active Locations (1)
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1
Kangdong Sacred Heart Hospital
Seoul, Gangdong-gu, South Korea, 05355