Menu
Enrolling by invitation NCT06965582

A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System

No phase Interventional Benign Prostatic Hyperplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALPFA BPH PFA System.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia, Italy, Panama
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia

Overview

The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH. Male subjects will be consented and undergo protocol-defined baseline assessments. Those who meet study entry criteria will be enrolled and treated with the ALPFA BPH PFA System and then undergo follow-up with protocol-defined assessment.

Interventions

  • Device ALPFA BPH PFA System
    PFA system for treatment of Benign Prostatic Hyperplasia

Primary outcome measures

  • Primary Safety Outcome [Time frame: 30 days]

Eligibility criteria

Inclusion:

  • Patients who are ≥ 45 years of age on the day of enrollment.
  • Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication.
  • Life expectancy: the patient has a life expectancy of ≥ 1 year
  • Patient participation: The patient
  • is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements.
  • is willing and capable of providing Informed Consent to undergo study procedures.
  • agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study.
  • lives close enough to the investigational site to facilitate the required in-person visits.

Exclusion:

  • 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:
  • Previous operative intervention for BPH
  • Active urinary tract infection (may be treated and enrolled upon negative urine culture).
  • Prostatitis: a history of any prostatitis within 2 years of enrollment.
  • Cystolithiasis active within 90 days of enrollment
  • artificial sphincters.
  • Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 2 centers
  • Brno University Hospital — Brno
  • Urologicka Klinika — Hradec Králové
Italy · 1 center
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
Panama · 1 center
  • Pacifica Salud Hospital — Panama City

Identifiers

NCT: NCT06965582 · CS-00001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗