Uropartners
Chicago, Illinois, 60612, United States
NCT Number: NCT04985123
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)
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Notify Me18 year–65 year
Male
Observational
Chicago, Illinois, 60612, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of Pre-Formed Penile Silicone Block Implant
Time frame: 8 weeks
Time frame: 3 months
Time frame: 8 weeks
Time frame: 3 months
Time frame: 8 weeks
Time frame: 3 months
International Medical Devices, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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