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

Penile Enhancement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496427
• Other study ID #: MT05-KR19PGE1101
• Status: Completed
• Start date: April 10, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 11, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Penile Enhancement

Locations

Country	Name	City	State
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul	Gangdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	18 months
Primary	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).	24 months