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

NCT06965582 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-16

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

ALPFA BPH PFA System

PFA system for treatment of Benign Prostatic Hyperplasia

Sponsors & Collaborators

  • ALPFA Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • Czechia
  • Italy
  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965582 on ClinicalTrials.gov