Penile ImplantNCT04985123
A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
An observational study of Penile Implant, run by International Medical Devices, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Penile Implant
- What is being tested?
- Pre-Formed Penile Silicone Block Implant
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 25 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Penile Implant
- Being tested
- Pre-Formed Penile Silicone Block Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Formed Penile Silicone Block ImplantDevice
Implantation of Pre-Formed Penile Silicone Block Implant
| Study group | Role | What they receive |
|---|---|---|
| Silicone Block patients | All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study. Receives: Device: Pre-Formed Penile Silicone Block Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events as Assessed by Observation
Measured: 8 weeks
Incidence of Adverse Events as Assessed by Observation
Measured: 3 months
Secondary outcomes (4)
Size of Flaccid Penile Girth as Measured by Physicians
Measured: 8 weeks
Size of Flaccid Penile Girth as Measured by Physicians
Measured: 3 months
Patient Reported Satisfaction as Assessed by Validated Questionnaires
Measured: 8 weeks
Patient Reported Satisfaction as Assessed by Validated Questionnaires
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start30 Jul 2021
- Primary completion25 Aug 2024
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Medical Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985123
- Sponsor's protocol ID
- Pro00036006
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
- ClinicalTrials.gov ID
- NCT04985123
- Acronym / sponsor ID
- Pro00036006
- Conditions
- Penile Implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Medical Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silicone Block patients | – | Device: Pre-Formed Penile Silicone Block ImplantAll subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Formed Penile Silicone Block ImplantImplantation of Pre-Formed Penile Silicone Block Implant | Device | Silicone Block patients |
Primary outcome
Incidence of Adverse Events as Assessed by Observation
Time frame: 8 weeks
Incidence of Adverse Events as Assessed by Observation
Time frame: 3 months
4 secondary outcomes
Size of Flaccid Penile Girth as Measured by Physicians
Time frame: 8 weeks
Size of Flaccid Penile Girth as Measured by Physicians
Time frame: 3 months
Patient Reported Satisfaction as Assessed by Validated Questionnaires
Time frame: 8 weeks
Patient Reported Satisfaction as Assessed by Validated Questionnaires
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Implant, run by International Medical Devices, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events as Assessed by Observation (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.