Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

Официальное название

Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction

Обзор

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.

Подробное описание

Erectile dysfunction (ED) is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners. Incidence of ED increases with age and is associated with depression, obesity, diabetes mellitus, hypertension, cardiovascular disease and benign prostatic hyperplasia. ED is diagnosed with symptoms of (1) inability to attain or sustain a penile erection during sexual activity and (2) a reduction of penile rigidity in \>75% of sexual encounters during six months period. ED is estimated to affect approximately 52% of men in age of 40 to 70 years.It is projected in 2025, the worldwide ED prevalence of about 322 million. ED usually has organic causes, such as damage of arteries, smooth muscle and fibrous tissue. This resuls in impairment of blood flow to and from penis due to diabetes, renal disease, atherosclerosis and vascular disease.

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.

Вмешательства

• Устройство Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
  Treatment: Erectile dysfunction

Первичные конечные точки

• The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v5.0 and IPP-specific mapping. [Срок оценки: 12 months]
• The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months. [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Durability [Срок оценки: 12 months]
• International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score [Срок оценки: Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.]
• Rosenberg Self-Esteem Scale (RSES) Total Score [Срок оценки: Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.]

Критерии участия

Критерии включения

• Male ≥22 years of age.
• Diagnosed with erectile dysfunction (impotence).
• Agree to receive Infla10® three-piece IPP as an ED treatment.
• Willing to complete all protocol required follow-up visits and tests.

Критерии исключения

• 1\. Contraindication to general anesthesia.
• Known allergy or sensitivity to product materials as indicated in the device labeling.
• Previous penile prosthesis or prior enlargement surgeries
• Diagnosed penile sensory neuropathy.
• Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
• Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
• Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
• Uncontrolled diabetes (Fasting Blood Sugar FBS) >300 or HbA1c ≥9.0 on morning of surgery)
• Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
• Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
• 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.
• 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.
• Lacking manual dexterity or mental abilities necessary to operate the device.
• Expected life expectancy < two years.
• Unwilling or unable to sign the Informed Consent.
• Unwilling or unable to comply with the follow-up study requirements.
• Currently participating in an investigational drug or another investigational device exemption (IDE) study.
• Incarcerated subjects
• Psychogenic erectile dysfunction

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 7 центров

• Wesley Hospital — Auchenflower
• Canberra Laparoscopic, Robotic & Laser Urology Centre — Garran
• Katelaris Urology — Hornsby
• St George Urology — Hurstville
• Advanced Urology Melbourne — Malvern
• Shire Urology — Miranda
• Urology South at Holmesglen Private Hospital — Moorabbin

Идентификаторы

NCT: NCT05574868 · RGN-ED-IPP-202201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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