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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone Block patients | All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-Formed Penile Silicone Block Implant | Device | Implantation of Pre-Formed Penile Silicone Block Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events as Assessed by Observation | 8 weeks | |
| Incidence of Adverse Events as Assessed by Observation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Size of Flaccid Penile Girth as Measured by Physicians | 8 weeks | |
| Size of Flaccid Penile Girth as Measured by Physicians | 3 months | |
| Patient Reported Satisfaction as Assessed by Validated Questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uropartners | Chicago | Illinois | 60612 | United States |
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| 8 weeks |
| Patient Reported Satisfaction as Assessed by Validated Questionnaires | 3 months |