Penile ImplantNCT02477189
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
An observational study of Penile Implant, run by International Medical Devices, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Implant
- What is being tested?
- Silicone Block
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2015
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men age 22 and older who had a penis implant from 2009-2014
Who may be able to join
- Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.
Who cannot join
- Medical records for the subject are not available for review or tabulation
- Subject did not comply with pre-operative or post-operative instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allen Kamrava, MD, MBA
Beverly Hills, California, 90211
About this study
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.
- Conditions
- Penile Implant
- Being tested
- Silicone Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone BlockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Group | This was the group that received the penis implant, consented for participation and completed the follow-up questionnaire. Receives: Procedure: Silicone Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Number of adverse events that occurred from implantation through the time of the study.
Measured: Up to 4 years, with an average of 2 years
Secondary outcomes (4)
Self-Esteem Score
Evaluation of a self-esteem score done pre-surgery and post-surgery
Measured: 7 days pre-surgery to 90 days post-surgery
Self-confidence score
Evaluation of a self-confidence score done pre-surgery and post-surgery
Measured: 7 days pre-surgery to 90 days post-surgery
Flaccid penile girth
Measurement of flaccid penile girth done pre-surgery and post-surgery
Measured: 7 days pre-surgery to 90 days post-surgery
Quality of Life Questionnaire
Measurement of issues with penis size from pre-surgery to post-surgery
Measured: 7 days pre-surgery to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 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
- NCT02477189
- Sponsor's protocol ID
- IMD-0115
- Status last verified
- Jun 2015
- First submitted
- 15 May 2015
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
- ClinicalTrials.gov ID
- NCT02477189
- Acronym / sponsor ID
- IMD-0115
- Conditions
- Penile Implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- International Medical Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Jun 2015 (estimated)
- 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 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: Silicone BlockThis was the group that received the penis implant, consented for participation and completed the follow-up questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men age 22 and older who had a penis implant from 2009-2014
Key inclusion criteria (1 listed)
- Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.
Key exclusion criteria (2 listed)
- Medical records for the subject are not available for review or tabulation
- Subject did not comply with pre-operative or post-operative instructions.
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 |
|---|---|---|
| Silicone Block | Procedure or surgery | Study Group |
Primary outcome
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.
4 secondary outcomes
Self-Esteem Score
Time frame: 7 days pre-surgery to 90 days post-surgery
Self-confidence score
Time frame: 7 days pre-surgery to 90 days post-surgery
Flaccid penile girth
Time frame: 7 days pre-surgery to 90 days post-surgery
Quality of Life Questionnaire
Time frame: 7 days pre-surgery to 90 days post-surgery
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 22 Jun 2015.
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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 1 inclusion and 2 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 22 Jun 2015. 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?
Number of Adverse Events (time frame: Up to 4 years, with an average of 2 years). 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 22 Jun 2015.