临床试验/NCT03840070

NCT03840070已完成不适用

A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

Medy-Tox1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2018年12月17日最近更新: 2020年7月29日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 20
试验地点: 1
主要终点: Subject satisfaction on the penile appearance at 12 months after application of Potenfill

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 19 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

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

排除标准

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

研究组 & 干预措施

Potenfill

Experimental

干预措施: Potenfill (Device)

结局指标

主要结局

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

时间窗: 12 month

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

次要结局

未报告次要终点

研究者

发起方

Medy-Tox

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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