Actively Recruiting
Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Led by Rigicon, Inc. · Updated on 2025-12-05
182
Participants Needed
7
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.
CONDITIONS
Official Title
Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 22 years of age or older
- Diagnosed with erectile dysfunction (impotence)
- Agree to receive Infla10�ae three-piece inflatable penile prosthesis as ED treatment
- Willing to complete all required follow-up visits and tests
You will not qualify if you...
- Contraindication to general anesthesia
- Known allergy or sensitivity to device materials
- Previous penile prosthesis or prior enlargement surgeries
- Diagnosed penile sensory neuropathy
- Fibrotic diseases such as priapism, Peyronie's disease, or Chordee
- Compromised immune system (e.g., lupus, scleroderma)
- Receiving immunosuppressive drugs or history of kidney transplant
- Uncontrolled diabetes (FBS >300 or HbA1c 9.0 on surgery day)
- Bleeding disorder or coagulopathy preventing safe procedure
- Active urogenital, skin, or systemic infection at assessment
- Significant or unstable comorbidities affecting safety or study results
- Cognitive disorders affecting communication or questionnaire completion
- Lacking manual dexterity or mental ability to operate the device
- Expected life expectancy less than two years
- Unwilling or unable to sign informed consent
- Unwilling or unable to comply with follow-up requirements
- Currently in another investigational drug or device study
- Incarcerated individuals
- Psychogenic erectile dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Wesley Hospital
Auchenflower, Australia
Actively Recruiting
2
Canberra Laparoscopic, Robotic & Laser Urology Centre
Garran, Australia
Actively Recruiting
3
Katelaris Urology
Hornsby, Australia
Actively Recruiting
4
St George Urology
Hurstville, Australia
Actively Recruiting
5
Advanced Urology Melbourne
Malvern, Australia
Actively Recruiting
6
Shire Urology
Miranda, Australia
Actively Recruiting
7
Urology South at Holmesglen Private Hospital
Moorabbin, Australia
Actively Recruiting
Research Team
Z
Zeynep Tin Konukcu
CONTACT
F
Feyzanur CALDIRAN, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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