ALPFA PFA System for Symptomatic Benign Prostatic Hyperplasia in Men Over 45
ALPFA BPH PFA System
Urogenital Diseases+3
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: February 7, 2025
Actual date on which the first participant was enrolled.This study is investigating a new treatment method for men over 45 who experience difficulty urinating due to an enlarged prostate, a condition known as Benign Prostatic Hyperplasia (BPH). The study is focused on evaluating the safety and effectiveness of the ALPFA BPH Pulsed Field Ablation (PFA) System. This system aims to provide relief from urinary symptoms by using a specific technique to treat the prostate. The study is important because it may offer a new option for managing BPH symptoms, which can significantly affect quality of life. Participants in the study will first undergo initial tests to ensure they meet the requirements to join. Those who qualify will receive treatment with the ALPFA BPH PFA System, a procedure that is part of the study protocol. After treatment, participants will have scheduled follow-up visits to monitor their progress and assess how well the treatment is working. The study does not specify any particular risks or benefits, as it is in the early stages, but close monitoring will help ensure participant safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion: 1. Patients who are ≥ 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. Life expectancy: the patient has a life expectancy of ≥ 1 year 4. Patient participation: The patient 1. is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements. 2. is willing and capable of providing Informed Consent to undergo study procedures. 3. agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study. 4. lives close enough to the investigational site to facilitate the required in-person visits. Exclusion: 1. 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: 1. Previous operative intervention for BPH 2. Active urinary tract infection (may be treated and enrolled upon negative urine culture). 3. Prostatitis: a history of any prostatitis within 2 years of enrollment. 4. Cystolithiasis active within 90 days of enrollment 5. artificial sphincters. 2. Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer 3. 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 \< 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 b. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy. c. Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis. d. Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant e. Active substance abuse: active alcoholism or
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Urologicka Klinika
Hradec Králové, CzechiaASST Grande Ospedale Metropolitano Niguarda
Milan, ItalyPacifica Salud Hospital
Panama City, Panama