To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic … (NCT07592299) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
250 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety-Incidence of Serious Device-or Procedure-Related Adverse Events (Composite Safety Endpoint)
Timeframe: Through 90 days post-procedure
2
Effectiveness-Change from Baseline in International Prostate Symptom Score (IPSS) at 3 Months.
Timeframe: Baseline to 3 months post-procedure
3
Effectiveness-Durability of Treatment Effect: Percent Change in International Prostate Symptom Score (IPSS) at 12 Months
. 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:
. 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.