Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
NCT ID: NCT05574868
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
182 participants
INTERVENTIONAL
2022-07-11
2026-05-21
Brief Summary
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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.
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Detailed Description
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Management of ED involves in life style modification, medical, surgical interventions, and possibly, in the future, tissue- engineering or cellular or gene therapy. Oral phosphodiesterase type 5 inhibitor (PDE5i), which works with sexual stimulation, is an effective medical therapy for ED with an excellent safety profile. Intracavernosal injection of or topical application vasoactive drug have also been studied. The first inflatable penile prosthesis was introduced in 1973 and current models of inflatable penile prostheses include the AMS 700 series, Coloplast Titan device and Zephyr ZSI device. A patient-activated inflatable penile prosthesis (IPP) provides patients a means to achieve dependable spontaneity for intercourse.
Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This proposed study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group
Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Treatment: Erectile dysfunction
Interventions
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Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Treatment: Erectile dysfunction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with erectile dysfunction (impotence).
3. Agree to receive Infla10® three-piece IPP as an ED treatment.
4. Willing to complete all protocol required follow-up visits and tests.
Exclusion Criteria
2. Known allergy or sensitivity to product materials as indicated in the device labeling.
3. Previous penile prosthesis or prior enlargement surgeries
4. Diagnosed penile sensory neuropathy.
5. Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
6. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
7. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
8. Uncontrolled diabetes (Fasting Blood Sugar FBS) \>300 or HbA1c ≥9.0 on morning of surgery)
9. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
10. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
11. Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
12. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
13. Lacking manual dexterity or mental abilities necessary to operate the device.
14. Expected life expectancy \< two years.
15. Unwilling or unable to sign the Informed Consent.
16. Unwilling or unable to comply with the follow-up study requirements.
17. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
18. Incarcerated subjects
19. Psychogenic erectile dysfunction
22 Years
MALE
No
Sponsors
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Rigicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Love, Dr.
Role: PRINCIPAL_INVESTIGATOR
Urology South at Holmesglen Private Hospital
Boon K. Kua, Dr.
Role: STUDY_DIRECTOR
Wesley Hospital
Hodo Haxhimolla, Dr.
Role: STUDY_DIRECTOR
Canberra Laparoscopic, Robotic & Laser Urology Centre
Phillip Katelaris, Dr.
Role: STUDY_DIRECTOR
Katelaris Urology
William Lynch, Dr.
Role: STUDY_DIRECTOR
St George Urology
Steven Wilson, Dr.
Role: STUDY_DIRECTOR
Department of Urology, Institute for Urologic Excellence
Paul Perito, MD
Role: STUDY_DIRECTOR
Perito Urology - Penile Implant Clinic
Gerard Testa, Dr.
Role: STUDY_DIRECTOR
Shire Urology
Daniel Moon, Dr.
Role: STUDY_DIRECTOR
Advanced Urology Melbourne
Locations
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Wesley Hospital
Auchenflower, , Australia
Canberra Laparoscopic, Robotic & Laser Urology Centre
Garran, , Australia
Katelaris Urology
Hornsby, , Australia
St George Urology
Hurstville, , Australia
Advanced Urology Melbourne
Malvern, , Australia
Shire Urology
Miranda, , Australia
Urology South at Holmesglen Private Hospital
Moorabbin, , Australia
Countries
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Central Contacts
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Other Identifiers
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RGN-ED-IPP-202201
Identifier Type: -
Identifier Source: org_study_id
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