CompletedNot Applicable

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

United States400 participantsStarted 2015-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure. Exclusion Criteria: * Medical records for the subject are not available for review or tabulation * Subject did not comply with pre-operative or post-operative instructions.

What they're measuring

Number of Adverse Events

Timeframe: Up to 4 years, with an average of 2 years

Trial details

NCT IDNCT02477189

SponsorInternational Medical Devices, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-05

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