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

NCT04985123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-03-27

No results posted yet for this study

Summary

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)

Conditions

  • Penile Implant

Interventions

DEVICE

Pre-Formed Penile Silicone Block Implant

Implantation of Pre-Formed Penile Silicone Block Implant

Sponsors & Collaborators

  • International Medical Devices, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2024-08-25
Completion
2025-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985123 on ClinicalTrials.gov