Efficacy and Safety of Potenfill for Temporary Penile Enh... | NCT03512717

Studies
Efficacy and Safety of Potenfill for Temporary Penile Enhancement

NCT03512717

Sponsor

Medy-Tox

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

76Actual

Phase

Not Applicable

Conditions

Penile Enhancement

Interventions

Potenfill
Powerfill

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

Mar 2019

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

Nov 16, 2017Actual

Primary Completion Date

Jul 31, 2018Actual

Completion Date

Jul 31, 2018Actual

First Submitted Date

Apr 27, 2018

First Submission Date that Met QC Criteria

Apr 27, 2018

First Posted Date

May 1, 2018Actual

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

Mar 25, 2019

Last Update Posted Date

Mar 26, 2019Actual

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

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

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Potenfill	Experimental		Device: Potenfill
Powerfill	Active Comparator		Device: Powerfill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Potenfill	Device	Maximum: 22ml	Potenfill
Powerfill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the Penile Circumference difference at 24 weeks from baseline	Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement	24 weeks

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)
be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
Subjects will sign an informed consent form

Exclusion Criteria:

Prior treatment for penile enhancement (e.g. fat, dermal graft).
Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
Allergic to hyalluronic acid.
Inflammatory or/and infectious disease on penis that can affect on this study

Accepts Healthy Volunteers

Yes

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
Gangdong Sacred Heart Hospital, Hallym Univ		Seoul			South Korea