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Penile Prosthesis
Inflatable Penile Prosthesis for Erectile Dysfunction
N/A
Recruiting
Led By Paul Perito, MD
Research Sponsored by Rigicon, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial looks at the long-term safety and effectiveness of a penile prosthesis for erectile dysfunction over 3 years. Patients are monitored after implantation to see how they respond to the prosthesis.
Who is the study for?
Men over 21 with erectile dysfunction can join this trial if they agree to use the Rigicon Infla10® prosthesis as treatment, can follow up on visits and tests, and have no allergies to device materials. Exclusions include those with anesthesia risks, previous penile surgeries, infections at surgery site or systemic infections, limited manual dexterity or mental capacity for device operation, life expectancy under two years, uncontrolled diabetes or significant other health issues.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction over a period of up to three years post-implantation. Participants will be monitored regularly following institutional standards for managing ED and any related conditions.See study design
What are the potential side effects?
Potential side effects may include pain at implant site, infection risk increase due to surgery, mechanical failure of the prosthesis leading to additional interventions or removals. Individual experiences may vary based on personal health factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rigidity at 12 months
Survival at 12 months
Secondary outcome measures
Serious complications
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis GroupExperimental Treatment1 Intervention
Male subjects 21 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
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Who is running the clinical trial?
Rigicon, Inc.Lead Sponsor
Paul Perito, MDPrincipal InvestigatorPerito Urology - Penile Implant Clinic
Muhammet Abdurrahim Imamoglu, MDStudy DirectorSBU Diskapi Yildirim Beyazit Training and Research Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder that may make procedures unsafe for me.I have been diagnosed with a fibrotic condition affecting my reproductive organs.You are willing to complete all protocol required follow-up visits and tests.I have been diagnosed with reduced sensation in my penis.I have a compromised immune system due to conditions like lupus or scleroderma.I am a man aged 21 or older.I have had surgery for penile prosthesis or enlargement before.I do not have any active infections, especially in the area where surgery is planned.I do not have any major health issues that could affect the study's safety or results.I have been diagnosed with erectile dysfunction.My fasting blood sugar is not over 300 on the morning of surgery.I can communicate clearly and understand the study's requirements.I agree to use Infla10® three-piece IPP for erectile dysfunction treatment.I cannot have general anesthesia due to health risks.I agree to use Infla10® as treatment for erectile dysfunction.I am a man aged 21 or older.I have been diagnosed with erectile dysfunction.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots available for this experiment that are open to participants?
"Affirmative. The details posted on clinicaltrials.gov demonstrate that this medical experiment is currently enrolling patients. Initially launched on July 11th 2022, the trial requires 177 participants to be recruited from a single centre."
Answered by AI
Who has the opportunity to join this medical experiment?
"This research is recruiting 177 volunteers between the ages of 21-90 with erectile dysfunction who meet additional criteria, such as being male and agreeing to receive a three-piece IPP for treatment. Participants must also commit to complete all necessary follow ups visits and tests required by the protocol."
Answered by AI
How many subjects are participating in this research endeavor?
"Affirmative. Clinicaltrials.gov illustrates that this experiment, first published on July 11th 2022, is recruiting participants at the moment. An estimated 177 individuals are needed to be acquired from one single centre for research purposes."
Answered by AI
Is this research open to participants over the age of thirty?
"The minimum age requirement for enrolment in this medical trial is 21 years old, with the maximum age set at 90."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Dr. Paul Perito / Perito Urology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What questions have other patients asked about this trial?
Are there and expenses involved?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have a venous leak and I want a permanent fix I am only 30 years old.
PatientReceived no prior treatments
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