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

A Single-center, Long-term, Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04496427

Enrollment

Registered

2020-08-03

Start date

2019-04-10

Completion date

2019-12-11

Last updated

2020-08-03

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

Conditions

Penile Enhancement

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 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

19 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline	18 months	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).
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline	24 months	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).

Countries

South Korea

Outcome results