A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.

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Detailed Description

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Conditions

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Penile Enhancement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Volus

Maxium: 22ml

Group Type EXPERIMENTAL

Volus/Powerfill

Intervention Type DEVICE

Maximum: 22ml

Powerfill

Maxium: 22ml

Group Type ACTIVE_COMPARATOR

Volus/Powerfill

Intervention Type DEVICE

Maximum: 22ml

Interventions

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Volus/Powerfill

Maximum: 22ml

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male subjects aged above 20 and below 65. (20≤male≥65)
2. 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?"
3. During the study period, subjects will not received any treatments associated with penile enhancement.
4. Subjects will sign an informed consent form

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes