[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07273773":3,"trial-entities:NCT07273773":117,"trial-summary:NCT07273773":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":49,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":72,"locations":75,"central_contacts":108,"overall_officials":114,"references":115,"see_also_links":116},"NCT07273773","RC2025_UNITED","Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction","Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study","RECRUITING","2029-07","2025-12","2026-08-13","2026-01-26","Rigicon, Inc.","INDUSTRY",true,"This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.","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 results in impairment of blood flow to and from penis due to diabetes, renal disease, atherosclerosis and vascular disease.\n\nManagement of ED involves lifestyle 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 or topical application of vasoactive drugs 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, and Coloplast Titan device. A patient-activated inflatable penile prosthesis (IPP) provides patients with a means to achieve dependable spontaneity for intercourse.\n\nRigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This 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.",[19],"Erectile Dysfunction (ED)",[21,22,23,24,25,26],"Rigicon","Infla10","inflatable penile prosthesis","penile prosthesis","Dynamic","erectile dysfunction","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},182,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Rigicon Infla10® Inflatable Penile Prosthesis (IPP)","Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis\n\n• Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction",[40],"Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis",[42,46],{"measure":43,"description":44,"timeFrame":45},"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 v6.0 and IPP-specific mapping.","Success will be concluded if the two-sided 95 percent confidence interval (equivalently, one-sided 97.5 percent) for the 12-month proportion has its lower bound strictly greater than 0.90 as specified in the statistical plan.","12 months",{"measure":47,"description":48,"timeFrame":45},"The primary effectiveness endpoint is a binary \"pass\" or \"fail\" objective axial rigidity test, assessed at 12 months.","The objective axial rigidity test will use a calibrated axial-rigidity device to measure vertical displacement of the fully inflated penis under a standardized 650-gram load. ≤15 mm displacement will be counted as a \"pass\".\n\nSuccess will be concluded if the two-sided 95 percent confidence interval for the 12-month success proportion has its lower bound strictly greater than the pre-specified performance goal in the statistical plan.",[50,53,57,60],{"measure":51,"description":52,"timeFrame":45},"Percentage of patients free from revision or explant surgeries at 12 months.","This secondary endpoint will summarize \"revision- or explant-free survival\" using Kaplan-Meier methods, with participants without an event right-censored at last contact.",{"measure":54,"description":55,"timeFrame":56},"International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score","The Erectile Function (EF) domain of the IIEF-15 questionnaire (Items 1-5 and 15) will be used to assess patient erectile function. Change from baseline in the EF domain total score will be reported at each time point. The questionnaire may be completed remotely via ePRO.\n\nScale \u002F Range: 6-30 points Direction: Higher scores indicate better erectile function. Assessment Schedule: Baseline and Months 3, 6, 12, 18, 24, and 36.","Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.",{"measure":58,"description":59,"timeFrame":56},"Rosenberg Self-Esteem Scale (RSES) Total Score","The 10-item Rosenberg Self-Esteem Scale (RSES) is a validated self-report instrument used to measure global self-worth by assessing positive and negative feelings about the self. The total RSES score will be used as a secondary endpoint to evaluate change in participant self-esteem and psychosocial well-being following device implantation.\n\nAdministration and scoring: Each item is rated on a 4-point Likert scale (1 = Strongly Disagree to 4 = Strongly Agree). Items 2, 5, 6, 8, and 9 are reverse scored. The total score ranges from 10 to 40, with higher scores indicating greater self-esteem.\n\nAnalysis: Change from baseline in total RSES score will be summarized at each time point as mean ± standard deviation with 95% confidence intervals, and formally tested within the pre-specified hierarchical secondary endpoint sequence.\n\nScale \u002F Range: 10-40 points Direction: Higher scores indicate higher self-esteem (better outcome).",{"measure":61,"description":62,"timeFrame":63},"Adverse Events","Descriptive tabulations by system organ class and preferred term, including device-relatedness and seriousness, and rates for typical post-IPP events categorized as AEs, SAEs, and UADEs.","36 months","MALE","22 Years",null,false,{"inclusion":69,"exclusion":70,"raw_text":71},[],[],"Inclusion Criteria:\n\n1. Male ≥22 years of age.\n2. Diagnosed with erectile dysfunction (impotence).\n3. Agree to receive Infla10® three-piece IPP as an ED treatment.\n4. Willing to complete all protocol required for follow-up visits and tests.\n\nExclusion Criteria:\n\n1. Contraindication to general anesthesia.\n2. Known allergy or sensitivity to product materials as indicated in the device labeling.\n3. Previous penile prosthesis or prior enlargement surgeries\n4. Diagnosed penile sensory neuropathy.\n5. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.\n6. Patients who are receiving chemotherapy at the time of enrolment.\n7. Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.\n8. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.\n9. Uncontrolled diabetes (HbA1c ≥ 9.0% \\[≈75 mmol\u002Fmol\\], measured within 90 days prior to surgery.\n10. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.\n11. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.\n12. Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \\[serum creatinine \\> 2.0 mg\u002Fdl\\], 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.\n13. Lacking manual dexterity or mental abilities necessary to operate the device.\n14. Expected life expectancy \\\u003C two years.\n15. Unwilling or unable to sign the Informed Consent.\n16. Unwilling or unable to comply with the follow-up study requirements.\n17. Psychogenic erectile dysfunction\n18. Currently participating in an investigational drug or another investigational device exemption (IDE) study.\n19. The cognitively challenged subjects and subjects with 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.\n20. Incarcerated subjects\n21. Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.",[73,74],"ADULT","OLDER_ADULT",[76,85,92,100],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Perito Urology","Coral Gables","Florida","33146","United States",{"lat":83,"lon":84},25.72149,-80.26838,{"facility":86,"status":8,"city":87,"state":79,"zip":88,"country":81,"geoPoint":89},"The University of South Florida Board of Trustees \u002F Tampa General Hospital","Tampa","33606",{"lat":90,"lon":91},27.94752,-82.45843,{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":81,"geoPoint":97},"Atlanta Cosmetic Urology","Atlanta","Georgia","30305",{"lat":98,"lon":99},33.749,-84.38798,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":81,"geoPoint":105},"Vitality Urology Institute","Houston","Texas","77024",{"lat":106,"lon":107},29.76328,-95.36327,[109],{"name":110,"role":111,"phone":112,"email":113},"Zeynep Tin Konukcu","CONTACT","888-202-9790","clinical@rigicon.com",[],[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Erectile Dysfunction",[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study planning to enroll 182 male participants. It is evaluating a medical device for erectile dysfunction.","completed","Rigicon Infla10® Inflatable Penile Prosthesis for Erectile Dysfunction","This study is looking at the long-term safety and how well the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) works for men with erectile dysfunction (ED). ED is when you have trouble getting or keeping an erection. The study will follow about 182 men who receive the Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis as a treatment for their ED. To join, you must be a male at least 22 years old, have ED, and agree to get the Infla10® IPP. The study will measure safety by checking for any device or procedure-related problems for 12 months. Effectiveness will be measured by how well the device helps with penile rigidity after 12 months.","Participants will be followed for up to 3 years after the implantation of the device. Safety and effectiveness will be measured at 12 months.",111,"You would receive the Infla10® three-piece IPP as an ED treatment and agree to complete all required follow-up visits and tests.","Not stated in the trial record.",[37],"v2"]