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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.

NCT07592299 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

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. When 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 Once ablation is complete, the catheter balloons will be deflated, and the catheter will be withdrawn from the urethra. Participants will then have follow-up visits with health checks as planned for this study.

DEVICE

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. Participants will then have follow-up visits with health checks as planned for this study.

Sponsors & Collaborators

  • ALPFA Medical

    lead INDUSTRY

Principal Investigators

  • Dr. Bilal Chughtai · The Smith Institute of Urology/Northwell Health

  • Dr. Dean Elterman · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2032-12-31
FDA Device
Yes

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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 NCT07592299 on ClinicalTrials.gov