[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641021":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":44,"locations":31,"responsibleParty":54,"collaborators":31,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":31,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":31,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":31},{"fullName":5,"class":6},"ALPFA Medical","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Device","ACTIVE_COMPARATOR","Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a treatment group and treated with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study",[13],"Device: Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Device","SHAM_COMPARATOR","Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a control group and treated with sham flexible cystoscopy (Control) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study",[19],"Device: Control Device: Sham flexible cystoscopy",{"label":21,"type":22,"description":23,"interventionNames":24},"Crossover Cohort","OTHER","Control Arm (Sham) patients can receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System after their 3-month follow-up assessments are completed, and participant symptom profile necessaites treatment and alll protocol defined enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment)Unless treated with the ALPFA GRAIL™ Pulsed Field Ablation(PFA)System, the subject will be exited from the study once they have completed their 3-month follow-up visit.",[13],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System","After the participant receives anesthesia, the Investigator will proceed with placement of the ALPFA GRAIL PFA Catheter into the prostate via a standard flexible cystoscope. Visualization of the prostatic urethra will determine the number of balloons that are exposed and inflated.\n\nWhen the catheter has been properly positioned, the ALPFA GRAIL PFA Console will be activated and one PFA application will be delivered. The Investigator will assess if the catheter needs to be repositioned and additional ablation applications delivered, as necessary. Once ablation is complete, the catheter balloons will be deflated, and the catheter will be withdrawn from the urethra.\n\nParticipants will then have follow-up visits with health checks as planned for this study.",[21,9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Control Device: Sham flexible cystoscopy","Participants will receive mock treatment with a flexible cystoscope with a working channel that is at least 6.9F in diameter. The cystoscope will be inserted and treatment script initiated. Once the script is completed, the cystoscope will be removed and procedural details captured on the relevant CRF.\n\nParticipants will then have follow-up visits with health checks as planned for this study.",[15],[37,41],{"name":38,"affiliation":39,"role":40},"Dr. Bilal Chughtai","The Smith Institute of Urology\u002FNorthwell Health","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"Dr. Dean Elterman","University Health Network, Toronto",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Anitha Achyutha","CONTACT","+1. 858.349.9550","aachyutha@alpfamedical.com",{"name":51,"role":47,"phone":52,"phoneExt":31,"email":53},"Jaya Kothule","+1 408.480.2859","jkothule@alpfamedical.com",{"type":55,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100641021","to-establish-the-safety-and-effectiveness-of-the-alpfa-grail-pfa-system-for-treating-symptomatic-benign-prostate-hyperplasia-bph-also-known-as-an-enlarged-prostate-100641021",false,"NCT07592299","To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.","A Prospective Randomized Pivotal Trial of the ALPFA Medical Prostate Ablation System Compared With Cystoscopy in Men With Symptomatic Benign Prostatic Hyperplasia","REBOUND","Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria to participate in this study as determined by the Investigator:\n\n1. ≥ 45 years of age on the day of enrollment.\n2. Symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s):\n\n   1. Symptom Score: Baseline IPSS score ≥13\n   2. Flow Rate: Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL\u002Fsec and ≤ 12 mL\u002Fs\n   3. Residual: ultrasound-determined PVR of ≤ 250 mL\n3. Prostate size 25-150 g, measured by transrectal ultrasound.\n4. Willing and able to provide consent and comply with study requirements.\n\nExclusion Criteria:Subjects will be excluded from the study if they meet any one of the following exclusion criteria, as determined by the Investigator:\n\n1. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:\n\n   1. Cardiovascular:\n\n      * History of clinically significant heart failure (NYHA III\u002FIV)\n      * Uncontrolled arrhythmia.\n      * Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, or any cardiac surgery within 180 days of enrollment.\n      * Uncontrolled hypertension\n   2. Renal: Serum creatinine \\> 2.0 mg\u002FdL or any history of renal dialysis or renal transplant.\n   3. Metabolic: Clinically uncontrolled diabetes mellitus or a baseline HbA1c ≥ 8.0%, or clinically significant liver disease.\n   4. Non-urologic cancer: Active malignancy, or within 3 years of enrollment, a history of treated malignancy now in full remission, except basal cell or squamous cell carcinoma of the skin.\n   5. Respiratory: Severe lung disease or respiratory illness requiring hospitalization.\n   6. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication, or current chemotherapy.\n   7. Transplant: Solid organ or hematologic transplant or currently being evaluated for an organ transplant.\n   8. Substance abuse: Active alcoholism or drug addiction.\n2. Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:\n\n   1. Operative: Previous prostate surgery or interventional procedure, including but not limited to BPH surgery, radiation, laser, prostate arterial embolism, balloon dilatation, or hyperthermic treatment, or prostate biopsy within 40 days of the Index Procedure.\n   2. Infection: Active urinary tract infection at the time of the Index Procedure (may be treated and enrolled upon negative urine culture).\n   3. Incontinence: History of urinary incontinence.\n   4. Retention: Requires indwelling catheter or intermittent catheterization to void or had an episode of spontaneous urinary retention within 30 days of enrollment.\n   5. Prostatitis: History of prostatitis within 2 years of enrollment.\n   6. Cystolithiasis: Active bladder stones\n   7. Neurogenic bladder: Neurogenic or atonic bladder or sphincter, including etiologies of uncontrolled diabetes, Parkinson's disease, multiple sclerosis, cerebrovascular accident, or polyneuropathy.\n   8. Anatomic abnormality: Prior or current urethral stricture, meatal stenosis, bladder neck contracture, or other urologic anatomic abnormalities that would interfere with planned treatment or confound subsequent assessment.\n   9. Implants: Any urinary tract implants including stents, sutures, penile implants, or artificial sphincters.\n   10. Hematuria: Hematuria without a known contributing factor within 90 days of the Index Procedure.\n3. Bladder cancer: Actively being treated or suspected cancer of the bladder.\n4. Baseline PSA \\> 10 ng\u002FmL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng\u002FmL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction following the site's standard of care.\n5. Prior pelvic or rectal interventions:\n\n   1. Previous pelvic irradiation or radical pelvic surgery\n   2. Previous rectal surgery (other than hemorrhoidectomy) or a history of rectal disease that may be impacted by Index Procedure.\n6. Peri-procedural anticoagulation: Unable to stop anti-platelet or anticoagulation treatment for the Index Procedure per site standard of care.\n7. Subjects who cannot or will not comply with the following washout medication requirements within the time period specified prior to enrollment:\n\n   1. 24-Hours:\n\n      * i. Taking phenylephrine or pseudoephedrine within 24 hours of the Baseline evaluation and Index Procedure.\n   2. 1 Week:\n\n      * i. Antihistamine, anticonvulsant, or antispasmodics medications within 1 week of enrollment unless documented on a stable (unchanged) for 180 days prior to enrollment.\n   3. 2 Weeks:\n\n      * i. Use of alpha blockers or daily dosage of PDE5 inhibitors (tadalafil \\[Cialis\\]) for BPH within 2 weeks prior to enrollment.\n      * ii. Use of anticholinergics or beta-3 adrenergic receptor agonists (e.g., mirabegron, vibegron) within 2 weeks prior to enrollment, unless documented on a stable dose for 30 days prior to enrollment.\n   4. 3 Months:\n\n      * i. Taking estrogen, drugs producing androgen suppression, or androgens within 90 days prior to enrollment, unless documented on a stable dosage for at least 90 days prior to enrollment.\n      * ii. Use of Type II 5-alpha reductase inhibitor medication (e.g., finasteride \\[Proscar, Propecia\\]) within 90 days of enrollment OR anticipated use within the first 12 months of follow-up.\n   5. 6 Months:\n\n      * i. Use of any Type I 5-alpha reductase inhibitor medication (e.g., dutasteride \\[Avodart\\]) within 180 days prior to enrollment OR anticipate use within the first 12 months of follow-up.\n      * ii. Taking tricyclic antidepressants that are not on a stable dose for the 180 days prior to enrollment OR anticipate stopping or changing treatment in the first 12 months of follow-up.\n8. Subjects who wish to maintain their fertility.\n9. Current or anticipated enrollment in any other randomized or interventional clinical study (registry or retrospective studies permitted).\n10. Vulnerable populations, including individuals who are incarcerated or institutionalized.Any physical, psychological, or developmental impairment (e.g., developmental delay) that, in the investigator's opinion, would compromise the subject's ability to provide informed consent, comply with study procedures, or complete patient-reported outcome measures.","MALE","45 Years",{"count":67,"type":68},250,"ESTIMATED","INTERVENTIONAL",[71],"NA","The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms. The study will involve up to 250 male participants who have urinary problems caused by BPH and whom are greater than 40 years of age in up to 30 investigational centers across the US,Canada and European Union.",[74],"Benign Prostatic Hyperplasia (BPH)",[76],"enlarged prostate","NOT_YET_RECRUITING","2026-05-11",{"date":80,"type":81},"2026-05-18","ACTUAL",{"date":83,"type":68},"2026-08",{"date":85,"type":68},"2032-12",{"name":5,"class":6}]