Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05574868
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-10-06
Brief Title:
Rigicon Infla10 Three-Piece Inflatable Penile Prosthesis ERASE ED
Sponsor:
Rigicon Inc
Organization:
Rigicon Inc
Study Overview
Official Title:
Evaluation of the Rigicon Infla10 Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 1 month 6 months 12 months18 months 24 months and 36 months post-procedure
Subjects will be followed per protocol and institutional standard of care for ED and comorbidities
This study will take approximately 6 months to enroll all subjects 14 days 1 month 6 months 12 months18 months 24 months and 36 months post-procedure
Subjects will be followed per protocol and institutional standard of care for ED and comorbidities
Detailed Description:
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 yearsIt 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None