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

NCT ID: NCT04496427

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2019-12-11

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kangdong Sacred Heart Hospital

Seoul, Gangdong-gu, South Korea

Countries

South Korea

Other Identifiers

MT05-KR19PGE1101

Identifier Type: -

Identifier Source: org_study_id