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A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985123
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
International Medical Devices, Inc.

Brief Summary:

This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant. Because the Silicone Block is placed subcutaneously, the device can provide immediate and permanent improvements to the appearance of a man's penis. The most notable improvements are enhanced penile cosmesis, improved penile girth, and improved exposure of the penile shaft outside the plane of the body.

The plan is to conduct a study to examine the outcomes of this procedure with respect to:

  • Incidences of adverse events
  • Changes in flaccid penile length (through physical measurements pre and post-operatively in a consistent manner)
  • Changes in flaccid penile girth (through physical measurements pre and post-operatively in a consistent manner)
  • Changes in satisfaction scores with respect to penile size and patient self-confidence/self-esteem (through validated questionnaires)

Condition or disease Intervention/treatment
Penile Implant Device: Pre-Formed Penile Silicone Block Implant

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : May 25, 2023
Estimated Study Completion Date : May 25, 2023

Group/Cohort Intervention/treatment
Silicone Block patients
All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.
Device: Pre-Formed Penile Silicone Block Implant
Implantation of Pre-Formed Penile Silicone Block Implant




Primary Outcome Measures :
  1. Incidence of Adverse Events as Assessed by Observation [ Time Frame: 8 weeks ]
  2. Incidence of Adverse Events as Assessed by Observation [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Size of Flaccid Penile Girth as Measured by Physicians [ Time Frame: 8 weeks ]
  2. Size of Flaccid Penile Girth as Measured by Physicians [ Time Frame: 3 months ]
  3. Patient Reported Satisfaction as Assessed by Validated Questionnaires [ Time Frame: 8 weeks ]
  4. Patient Reported Satisfaction as Assessed by Validated Questionnaires [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.
Criteria

Inclusion Criteria:

  • Inclusion criteria include men who are over 18 and under 65, circumcised, who have the perception of inadequate penile girth or appearance of length of penis, or penile deviation from straight plane in flaccid condition for whatever reason. Etiologies may include:
  • A retractile penis or "buried penis" from infrapubic pannus
  • A loss of length following radical prostatectomy or other trauma
  • Congenital or acquired (e.g., Peyronie's Disease) mild curvature of the penis with indentation deformity and with curvature less than 30 degrees with no plan to have other corrective procedures (e.g. surgery, intralesional injection of collagenase clostridium histolyticum)
  • Patient perception of a penis of inadequate size and patient desire for cosmetic enhancement

Exclusion Criteria:

  • Men who are unable to give informed consent
  • An uncircumcised penis
  • Micro-penis (stretched flaccid penile length <6cm)
  • Prior penile girth enhancement procedure of any sort, including grafts or subcutaneous injections, previous Xiaflex injection
  • History of immunosuppression and/or HIV
  • Men who are on anti-coagulation medication which cannot be stopped
  • Uncontrolled diabetes
  • Active genitourinary skin infection
  • History of recurrent or active urinary tract infection (UTI)
  • Patients unwilling to comply with post-operative instructions
  • Patients who smoke and are unwilling to stop 2 weeks before surgery and for at least 6 weeks after surgery.

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): NCT04985123


Contacts
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Contact: Laurence Levine (312) 563-5000 drlevine@hotmail.com

Locations
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United States, Illinois
Uropartners Recruiting
Chicago, Illinois, United States, 60612
Contact: Laurence Levine, MD    312-563-5000    drlevine@hotmail.com   
Sponsors and Collaborators
International Medical Devices, Inc.
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Responsible Party: International Medical Devices, Inc.
ClinicalTrials.gov Identifier: NCT04985123    
Other Study ID Numbers: Pro00036006
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No