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 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CS00004
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

enlarged prostate

Outcome Measures

Primary Outcomes (3)

• Safety-Incidence of Serious Device-or Procedure-Related Adverse Events (Composite Safety Endpoint)

  The primary safety endpoint is the proportion of participants experiencing one or more of the following serious device-related or procedure-related adverse events: Internal Tears: Any accidental holes or tears in the rectum, bladder, or digestive tract. Abnormal Connections (Fistula): The development of an unintended opening or passage between the rectum and the tube that carries urine (urethra). Inability to Urinate: A new, ongoing problem where a participant cannot empty their bladder and requires a tube (catheter) for more than 28 days after the procedure. Leaking Urine: New or persistent "stress incontinence," which is the accidental leaking of urine during physical activity, coughing, or sneezing. Severe Bleeding: Any bleeding serious enough to require a blood transfusion or a follow-up surgery to stop it. Injury to the urinary tube (urethra) or the lining of the prostate (capsule) that is severe enough to require surgery.

  Through 90 days post-procedure

• Effectiveness-Change from Baseline in International Prostate Symptom Score (IPSS) at 3 Months.

  The International Prostate Symptom Score (IPSS) is a 7-item questionnaire (score range 0-35) where higher scores indicate more severe symptoms. Success is defined as the Treatment group showing a 25% greater relative improvement in mean score compared to the Control group

  Baseline to 3 months post-procedure

• Effectiveness-Durability of Treatment Effect: Percent Change in International Prostate Symptom Score (IPSS) at 12 Months

  This endpoint evaluates the long-term effectiveness of the ALPFA GRAIL PFA System. It is calculated as the mean percentage change in the total International Prostate Symptom Score (IPSS) score from the start of the study (baseline) to the 12-month follow-up for participants in the treatment group.

  Baseline to 12 months post-procedure

Secondary Outcomes (3)

• Additional Study Goals

  3 months

• Success Stories (Responder Rate)

  3 months

• Improvement in Urine Flow

  3 months

Study Arms (3)

Treatment Device

ACTIVE COMPARATOR

Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a treatment group and treated with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study

Device: Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System

Control Device

SHAM COMPARATOR

Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a control group and treated with sham flexible cystoscopy (Control) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study

Device: Control Device: Sham flexible cystoscopy

Crossover Cohort

OTHER

Control Arm (Sham) patients can receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System after their 3-month follow-up assessments are completed, and participant symptom profile necessaites treatment and alll protocol defined enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment)Unless treated with the ALPFA GRAIL™ Pulsed Field Ablation(PFA)System, the subject will be exited from the study once they have completed their 3-month follow-up visit.

Device: Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System

Interventions

Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System DEVICE

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.

Crossover Cohort; Treatment Device

Control Device: Sham flexible cystoscopy DEVICE

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.

Control Device

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 45 years of age on the day of enrollment.
• Symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s):
• Symptom Score: Baseline IPSS score ≥13
• Flow Rate: Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 12 mL/s
• Residual: ultrasound-determined PVR of ≤ 250 mL
• Prostate size 25-150 g, measured by transrectal ultrasound.
• Willing and able to provide consent and comply with study requirements.

You may not qualify if:

• 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:
• Cardiovascular:
• History of clinically significant heart failure (NYHA III/IV)
• Uncontrolled arrhythmia.
• Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, or any cardiac surgery within 180 days of enrollment.
• Uncontrolled hypertension
• Renal: Serum creatinine \> 2.0 mg/dL or any history of renal dialysis or renal transplant.
• Metabolic: Clinically uncontrolled diabetes mellitus or a baseline HbA1c ≥ 8.0%, or clinically significant liver disease.
• Non-urologic cancer: Active malignancy, or within 3 years of enrollment, a history of treated malignancy now in full remission, except basal cell or squamous cell carcinoma of the skin.
• Respiratory: Severe lung disease or respiratory illness requiring hospitalization.
• Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication, or current chemotherapy.
• Transplant: Solid organ or hematologic transplant or currently being evaluated for an organ transplant.
• Substance abuse: Active alcoholism or drug addiction.
• 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:
• Operative: Previous prostate surgery or interventional procedure, including but not limited to BPH surgery, radiation, laser, prostate arterial embolism, balloon dilatation, or hyperthermic treatment, or prostate biopsy within 40 days of the Index Procedure.

Sponsors & Collaborators

• ALPFA Medical: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Dr. Bilal Chughtai

  The Smith Institute of Urology/Northwell Health

  PRINCIPAL INVESTIGATOR

• Dr. Dean Elterman

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anitha Achyutha

CONTACT

+1. 858.349.9550; aachyutha@alpfamedical.com

Jaya Kothule

CONTACT

+1 408.480.2859; jkothule@alpfamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient and site personnel administering follow-up assessments to 3 months will be blinded to the study assignment. Unblinding will occur at 3 months post procedure after follow-up assessments are completed. All patients will be asked post-treatment if they believe they are in the Treatment Arm, Control Arm, or do not know. The blinding questionnaire will be administered at discharge,1-month, and 3-month follow-up assessments. Control Arm patients can receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System within 3 months after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, multinational, 2:1 randomized, double-blinded, sham-controllled clinical trial of the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System. Following unblinding, sham-controlled patients may elect to receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA)System or exit the study.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2032
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share