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

Medy-Tox13 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Penile Enhancement

Eligibility

Sex: MALEMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kangdong Sacred Heart Hospital

Seoul, Gangdong-gu, South Korea

Outcomes

Primary Outcomes

Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline

Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).

Time frame: 18 months

Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline

Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).

Time frame: 24 months

Data from ClinicalTrials.gov

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