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Ensaio clínico

A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery

NCT: NCT04985123 · COMPLETED

ID NCTNCT04985123
EstadoCOMPLETED
Data de início2021-07-30
Conclusão2025-04-25

Resumo breve

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)

Fonte oficial

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