Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: The ALPFA BPH PFA System is comprised of the following:
ALPFA BPH PFA Catheter and Extension Cable
ALPFA BPH PFA Generator System: The intervention involves pulsed field ablation
Sponsors
ALPFA Medical, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are greater than equal to 45 years of age on the day of enrollment. 2. Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication. 3. Patients with symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s): a. Symptom Score: a baseline IPSS score of 13 or greater
Exclusion criteria
Exclusion criteria: 1. 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: a. Unstable cardiovascular disease including: i. NYHA III/IV heart failure or LVEF less than 40% ii. Uncontrolled arrhythmia iii. Stroke, TIA, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment. iv. Uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 95 mmHg on two (2) BP measurements taken at least 3 minutes apart at baseline assessment). b. Renal: Serum creatinine greater than 1.8 or any history of renal dialysis or renal transplant c. Nonurologic cancer: Active malignancy (other than cutaneous basal cell or squamous cell carcinoma d. Metabolic: clinically uncontrolled diabetes mellitus or a baseline HbA1c greater than equal to 8.0%, or clinically significant liver disease e. Respiratory: Any lung disease involving abnormal blood gases or significant dyspnea f. Infection: active systemic infection g. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy. h. Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis. i. Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant j. Active substance abuse: active alcoholism or drug addiction 2. 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: a. Previous operative intervention for BPH b. Active urinary tract infection (may be treated and enrolled upon negative urine culture). c. Incontinence: catheter dependent or had an episode of spontaneous urinary retention within 90 days of enrollment. d. Prostatitis: a history of any prostatitis within 2 years of enrollment. e. Cystolithiasis active within 90 days of enrollment f. Neurogenic bladder: neurogenic or atonic bladder, including etiologies of uncontrolled diabetes, Parkinson s disease, multiple sclerosis, stroke/TIA or polyneuropathy. g. 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 (potentially an intra-procedural exclusion). h. Implants: any urinary tract implants including stents, penile implants or artificial sphincters. 3. Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer. 4. Prostate cancer: a. Known or clinically suspected prostate cancer b. A PSA value greater than 10 ng/ml c. If PSA is greater than 2.5 ng/ml and less than equal to 10 ng/ml, prostate cancer must be ruled out via an MRI study 5. Concomitant medications: please see Section 6.2 for enrollment restrictions on medications for subject participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: The safety endpoint for Phases Two and Three of this study is a Composite Safety Endpoint (CSE) defined as the proportion of subjects with one or more device- or procedure-related serious adverse events (SAEs) through 30 days post-procedure. Primary Effectiveness Endpoint: All subjects will be assessed for symptomatic improvement using the International Prostate Symptom Score (IPSS) instrument. The change from baseline and the responder rate will be assessed at 90, 180 and 360 days.Timepoint: 30, 90, 180, 360 days after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in prostate symptom score, urinary flow parameters, prostate size, quality of life, and sexual function following treatmentTimepoint: 7 days, 30 days, 90 days, 180 days and 360 days post procedure | — |
Countries
Czech Republic, India, Italy
Contacts
Public ContactMeena Dalal
Urokul Hospital
Outcome results
None listed