Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

Completed

Conditions studied: Penile Implant

In brief

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.

Key facts

Study ID

NCT02477189

Run by

International Medical Devices, Inc.

People needed

400

Starts

2015-04-01

Expected to finish

2015-05-01

Last updated by the study team

2015-06-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.

You may not qualify if…

• Medical records for the subject are not available for review or tabulation
• Subject did not comply with pre-operative or post-operative instructions.

Where it is running

• Allen Kamrava, MD, MBA — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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