NCT04985123已完成不适用
A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
International Medical Devices, Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events as Assessed by Observation
研究概览
简要总结
This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant. Because the Silicone Block is placed subcutaneously, the device can provide immediate and permanent improvements to the appearance of a man's penis. The most notable improvements are enhanced penile cosmesis, improved penile girth, and improved exposure of the penile shaft outside the plane of the body.
The plan is to conduct a study to examine the outcomes of this procedure with respect to:
- Incidences of adverse events
- Changes in flaccid penile length (through physical measurements pre and post-operatively in a consistent manner)
- Changes in flaccid penile girth (through physical measurements pre and post-operatively in a consistent manner)
- Changes in satisfaction scores with respect to penile size and patient self-confidence/self-esteem (through validated questionnaires)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria include men who are over 18 and under 65, circumcised, who have the perception of inadequate penile girth or appearance of length of penis, or penile deviation from straight plane in flaccid condition for whatever reason. Etiologies may include:
- •A retractile penis or "buried penis" from infrapubic pannus
- •A loss of length following radical prostatectomy or other trauma
- •Congenital or acquired (e.g., Peyronie's Disease) mild curvature of the penis with indentation deformity and with curvature less than 30 degrees with no plan to have other corrective procedures (e.g. surgery, intralesional injection of collagenase clostridium histolyticum)
- •Patient perception of a penis of inadequate size and patient desire for cosmetic enhancement
排除标准
- •Men who are unable to give informed consent
- •An uncircumcised penis
- •Micro-penis (stretched flaccid penile length <6cm)
- •Prior penile girth enhancement procedure of any sort, including grafts or subcutaneous injections, previous Xiaflex injection
- •History of immunosuppression and/or HIV
- •Men who are on anti-coagulation medication which cannot be stopped
- •Uncontrolled diabetes
- •Active genitourinary skin infection
- •History of recurrent or active urinary tract infection (UTI)
- •Patients unwilling to comply with post-operative instructions
- •Patients who smoke and are unwilling to stop 2 weeks before surgery and for at least 6 weeks after surgery.
结局指标
主要结局
Incidence of Adverse Events as Assessed by Observation
时间窗: 3 months
Incidence of Adverse Events as Assessed by Observation
时间窗: 8 weeks
次要结局
- Size of Flaccid Penile Girth as Measured by Physicians(3 months)
- Patient Reported Satisfaction as Assessed by Validated Questionnaires(3 months)
- Size of Flaccid Penile Girth as Measured by Physicians(8 weeks)
- Patient Reported Satisfaction as Assessed by Validated Questionnaires(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Safety and Efficacy of a Sub-epitheilal Transform™ Corneal Allograft (TCA) for Presbyopia CorrectionRefractive ErrorsPresbyopiaNCT03675438Allotex, Inc.
已完成
3 期
A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRTHuman Immunodeficiency Virus InfectionsNCT00727597Georgetown University101
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIKMyopiaHyperopiaPresbyopiaNCT01977807Technolas Perfect Vision GmbH100
已完成
不适用
A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.Fabry DiseaseNCT00233870Genzyme, a Sanofi Company405
Unknown
4 期
A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and PresbyopiaHyperopiaPresbyopiaMyopiaNCT02112968Technolas Perfect Vision GmbH97