Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
enlarged prostate
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.
Detailed description
This study aims to test how safe and effective the ALPFA BPH PFA System is for treating men over age 40 who have urinary problems caused by an enlarged prostate (BPH).The study will involve up to 250 participants in up to 30 investigational centers across the US, Canada, and European Union. Men who agree to join the study will have health checks before treatment. Those who meet the study eligibility criteria including medication washout requirements,will be placed by chance into one of two groups. Two out of three men will receive treatment with the ALPFA BPH PFA System. One out of three men will receive a sham procedure that looks like treatment but does not deliver treatment.Participants will be followed for longer term safety and effectiveness for a total of 5 years post treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System. Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit. After 3 months, participants will be told which group they were in. Men who were in the sham group may choose to receive treatment with the ALPFA BPH PFA System. Men in the sham group who do not choose treatment by 6 months will no longer take part in the study. All men who receive treatment will have follow-up visits at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months. After that, they will be checked once a year for up to 5 years.
Interventions
DEVICETreatment 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.
DEVICEControl 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
ALPFA Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study subjects are required to meet all the following inclusion criteria to participate in this study as determined by the Investigator: 1. ≥ 45 years of age on the day of enrollment. 2. Symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s): 1. Symptom Score: Baseline IPSS score ≥13 2. Flow Rate: Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 12 mL/s 3. Residual: ultrasound-determined PVR of ≤ 250 mL 3. Prostate size 25-150 g, measured by transrectal ultrasound. 4. Willing and able to provide consent and comply with study requirements.
Exclusion criteria
Subjects will be excluded from the study if they meet any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety-Incidence of Serious Device-or Procedure-Related Adverse Events (Composite Safety Endpoint) | Through 90 days post-procedure | 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. |
| Effectiveness-Change from Baseline in International Prostate Symptom Score (IPSS) at 3 Months. | Baseline to 3 months post-procedure | 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 |
| Effectiveness-Durability of Treatment Effect: Percent Change in International Prostate Symptom Score (IPSS) at 12 Months | Baseline to 12 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Stories (Responder Rate) | 3 months | 2\. Number of "Success Stories" (Responder Rate) The study will count how many participants had a meaningful improvement in their symptoms. A "responder" (a success) is defined as a person whose symptoms improved by at least 30% three months after the treatment. |
| Improvement in Urine Flow | 3 months | 3\. Improvement in Urine Flow (Qmax) Researchers will measure the strength of the participant's urine flow. They will compare the average change in flow strength from the start of the study to three months later between the treatment group and the control group. |
| Additional Study Goals | 3 months | 1.Comparison of Symptom Improvement (at 3 Months) Researchers will compare the average change in prostate symptoms between the group that received the study treatment and the control group. This helps show if the treatment provides more relief than the standard comparison. |
Contacts
CONTACTAnitha Achyutha
CONTACTJaya Kothule
PRINCIPAL_INVESTIGATORDr. Bilal Chughtai
The Smith Institute of Urology/Northwell Health
PRINCIPAL_INVESTIGATORDr. Dean Elterman
University Health Network, Toronto
Outcome results
None listed