The Efficacy and Safety of Repeat-dose Potenfill for Temp... | NCT03840070

Studies
The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

NCT03840070

Sponsor

Medy-Tox

Status

Completed

Last Update Posted

Jul 29, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Penile Girth Enhancement
Penile Enhancement

Interventions

Potenfill

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2018Actual

Primary Completion Date

Oct 17, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Feb 7, 2019

First Submission Date that Met QC Criteria

Feb 11, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2020

Last Update Posted Date

Jul 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Potenfill	Experimental		Device: Potenfill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Potenfill	Device	Maximum: 22ml	Potenfill	hyaluronic acid filler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea university guro hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided