NCT02477189已完成不适用
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
International Medical Devices, Inc.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.
排除标准
- •Medical records for the subject are not available for review or tabulation
- •Subject did not comply with pre-operative or post-operative instructions.
结局指标
主要结局
Number of Adverse Events
时间窗: Up to 4 years, with an average of 2 years
Number of adverse events that occurred from implantation through the time of the study.
次要结局
- Self-Esteem Score(7 days pre-surgery to 90 days post-surgery)
- Quality of Life Questionnaire(7 days pre-surgery to 90 days post-surgery)
- Self-confidence score(7 days pre-surgery to 90 days post-surgery)
- Flaccid penile girth(7 days pre-surgery to 90 days post-surgery)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With DyslipidaemiaDyslipidemiasNCT04862962Laboratorios Silanes S.A. de C.V.120
已完成
3 期
Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis PigmentosaX-Linked Retinitis PigmentosaChoroideremiaNCT03584165NightstaRx Ltd, a Biogen Company277
Unknown
不适用
Retrospective Study on the Efficacy and Tolerability of Liposomal IrinotecanMetastatic Pancreatic Ductal AdenocarcinomaNCT05095064University Hospital, Antwerp60
招募中
不适用
Retrospective analysis for the safety and efficacy of maneuver, the treatment outcomes, and the prognosis among patients for whom percutaneous cryoablation is performed.JPRN-UMIN000007175Keio University School of medicine1,000
尚未招募
不适用
RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)Guided Bone RegenerationNCT06570265Hyundai Bioland Co., Ltd.50