- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02477189
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
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
-
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California
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Beverly Hills, California, United States, 90211
- Allen Kamrava, MD, MBA
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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.
|
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
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Number of adverse events that occurred from implantation through the time of the study.
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Up to 4 years, with an average of 2 years
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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
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7 days pre-surgery to 90 days post-surgery
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Self-confidence score
Time Frame: 7 days pre-surgery to 90 days post-surgery
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Evaluation of a self-confidence score done pre-surgery and post-surgery
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7 days pre-surgery to 90 days post-surgery
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Flaccid penile girth
Time Frame: 7 days pre-surgery to 90 days post-surgery
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Measurement of flaccid penile girth done pre-surgery and post-surgery
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7 days pre-surgery to 90 days post-surgery
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Quality of Life Questionnaire
Time Frame: 7 days pre-surgery to 90 days post-surgery
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Measurement of issues with penis size from pre-surgery to post-surgery
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7 days pre-surgery to 90 days post-surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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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