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

June 19, 2015 updated by: International Medical Devices, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Allen Kamrava, MD, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men age 22 and older who had a penis implant from 2009-2014

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
This was the group that received the penis implant, consented for participation and completed the follow-up questionnaire.
Procedure: Silicone Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 years, with an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days pre-surgery to 90 days post-surgery
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
7 days pre-surgery to 90 days post-surgery
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
7 days pre-surgery to 90 days post-surgery
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
7 days pre-surgery to 90 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Medical Devices, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Estimate)

June 22, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • IMD-0115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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