Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Medytox

Status: Completed

Conditions: Penile Enhancement

Study type: Observational

Funder types: Industry

Identifiers

NCT04496427

MT05-KR19PGE1101

Details and patient eligibility

About

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 study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.

Enrollment: 13 patients

Sex: Male

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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