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

NCT04496427 | Completed

• 1 other identifier: MT05-KR19PGE1101
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Enhancement

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Kangdong Sacred Heart Hospital

Seoul, Gangdong-gu, 05355, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 3, 2020
• Study Start: April 10, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 11, 2019
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

KR (1)