Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Primary Purpose
Erectile Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring inflatable penile prosthesis, penile prosthesis, Infla10, Rigicon
Eligibility Criteria
Inclusion Criteria:
- Male ≥21 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.
Exclusion Criteria:
- 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
- Uncontrolled diabetes (FBS >300 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.
Sites / Locations
- SBU Diskapi Yildirim Beyazit Training and Research HospitalRecruiting
- Haydarpasa Numune Training and Research HospitalRecruiting
- Kavacik Medistate HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group
Arm Description
Male subjects 21 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
Outcomes
Primary Outcome Measures
Rigidity at 12 months
Physician measurement of the rigidity of the fully inflated device at 12 months post-implant
Survival at 12 months
Freedom from surgical revision at 12 months post-procedure
Secondary Outcome Measures
Serious complications
Incidence of device or procedure-related serious complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05574868
Brief Title
Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Official Title
Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
May 21, 2026 (Anticipated)
Study Completion Date
May 21, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigicon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
inflatable penile prosthesis, penile prosthesis, Infla10, Rigicon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group
Arm Type
Other
Arm Description
Male subjects 21 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
Intervention Type
Device
Intervention Name(s)
Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Other Intervention Name(s)
IPP
Intervention Description
Treatment: Erectile dysfunction
Primary Outcome Measure Information:
Title
Rigidity at 12 months
Description
Physician measurement of the rigidity of the fully inflated device at 12 months post-implant
Time Frame
12 months
Title
Survival at 12 months
Description
Freedom from surgical revision at 12 months post-procedure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Serious complications
Description
Incidence of device or procedure-related serious complications
Time Frame
36 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male ≥21 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.
Exclusion Criteria:
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
Uncontrolled diabetes (FBS >300 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orhan Koca, MD
Phone
+90 532 562 15 13
Email
drorhankoca@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Metin Ishak Ozturk, MD
Phone
+90 532 245 94 17
Email
drmetinozturk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammet Abdurrahim Imamoglu, MD
Organizational Affiliation
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Musab Ali Kutluhan, MD
Organizational Affiliation
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Metin Ishak Ozturk, MD
Organizational Affiliation
SBU Haydarpasa Numune Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orhan Koca, MD
Organizational Affiliation
Kavacik Medistate Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Onder Kayigil, MD
Organizational Affiliation
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven K. Wilson, MD
Organizational Affiliation
Department of Urology, Institute for Urologic Excellence
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Perito, MD
Organizational Affiliation
Perito Urology - Penile Implant Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Duygu Kirkik, PhD
Organizational Affiliation
Rigicon, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
SBU Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Haydarpasa Numune Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kavacik Medistate Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
We'll reach out to this number within 24 hrs