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

Hugel

Status and phase: Completed; Phase 3

Conditions: Penile Enhancement

Treatments: Device: Volus/Powerfill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02833532

AC-Volus-01

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Volus

Experimental group

Description:

Maxium: 22ml

Treatment:

Device: Volus/Powerfill

Powerfill

Active Comparator group

Description:

Maxium: 22ml

Treatment:

Device: Volus/Powerfill