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Trial record 23 of 494 for:    penis

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

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ClinicalTrials.gov Identifier: NCT02477189
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
International Medical Devices, Inc.

Brief 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.

Condition or disease Intervention/treatment
Penile Implant Procedure: Silicone Block

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men age 22 and older who had a penis implant from 2009-2014
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477189


Locations
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United States, California
Allen Kamrava, MD, MBA
Beverly Hills, California, United States, 90211
Sponsors and Collaborators
International Medical Devices, Inc.

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Responsible Party: International Medical Devices, Inc.
ClinicalTrials.gov Identifier: NCT02477189     History of Changes
Other Study ID Numbers: IMD-0115
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015