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OpenTrials
Completed

NCT Number: NCT02477189

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

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.

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Key information

Conditions

Penile Implant

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Allen Kamrava, MD, MBA

Beverly Hills, California, 90211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silicone Block

Procedure

Primary outcomes

  1. Number of Adverse Events

    Time frame: Up to 4 years, with an average of 2 years

    Number of adverse events that occurred from implantation through the time of the study.

Secondary outcomes

  1. Self-Esteem Score

    Time frame: 7 days pre-surgery to 90 days post-surgery

    Evaluation of a self-esteem score done pre-surgery and post-surgery

  2. Self-confidence score

    Time frame: 7 days pre-surgery to 90 days post-surgery

    Evaluation of a self-confidence score done pre-surgery and post-surgery

  3. Flaccid penile girth

    Time frame: 7 days pre-surgery to 90 days post-surgery

    Measurement of flaccid penile girth done pre-surgery and post-surgery

  4. Quality of Life Questionnaire

    Time frame: 7 days pre-surgery to 90 days post-surgery

    Measurement of issues with penis size from pre-surgery to post-surgery

Sponsors and collaborators

Lead sponsor

International Medical Devices, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2015
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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