NCT03840070

Brief Summary

This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis. This study will determine the long-term efficacy and safety of Potenfill.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

February 7, 2019

Last Update Submit

July 27, 2020

Conditions

Penile Girth EnhancementPenile Enhancement

Outcome Measures

Primary Outcomes (1)

  • Subject satisfaction on the penile appearance at 12 months after application of Potenfill

    Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.

    12 month

Study Arms (1)

Potenfill

EXPERIMENTAL
Device: Potenfill

Interventions

PotenfillDEVICE

Maximum: 22ml

Also known as: hyaluronic acid filler
Potenfill

Eligibility Criteria

Age19 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects aged above 19 and below 65. (20≤male≥65)
  • Subjects will sign an informed consent form

You may not qualify if:

  • Prior treatment for penile enhancement (e.g. fat, dermal graft).
  • Allergic to hyalluronic acid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university guro hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 15, 2019

Study Start

December 17, 2018

Primary Completion

October 17, 2019

Study Completion

December 30, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

KR(1)