Benign Prostatic Hyperplasia study: The ALPFA Medical
Official title 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.
ClinicalTrials.gov ID: NCT07592299
What this study is testing
- What it's testing
- This study aims to check if the ALPFA GRAIL system is safe and works well for treating enlarged prostate symptoms.
- Who it's for
- The study is looking for men over 40 who have urinary problems caused by an enlarged prostate.
- What's involved
- Participants will receive treatment with the ALPFA GRAIL system, which uses pulsed energy to treat the prostate.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- Time commitment: about 5 years
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- ≥ 45 years of age on the day of enrollment.
- Symptom Score: Baseline IPSS score ≥13
- Flow Rate: Uroflow test with a pre-void bladder volume ≥150 mL (confirmed by bladder scan),Single uroflow test with a minimum voided volume ≥ 125 mL...
- Residual: ultrasound-determined PVR of ≤ 250 mL
- Prostate size 25-150 g, measured by transrectal ultrasound.
You likely can't join if
- 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 (\> 160 mmHg systolic or \> 95 mmHg diastolic on repeat measurements)
- 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.
See the full eligibility criteria
Who can join
- ≥ 45 years of age on the day of enrollment.
- Symptom Score: Baseline IPSS score ≥13
- Flow Rate: Uroflow test with a pre-void bladder volume ≥150 mL (confirmed by bladder scan),Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 15 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.
What rules you out
- 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 (\> 160 mmHg systolic or \> 95 mmHg diastolic on repeat measurements)
- 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.
- Sleep apnea: Known moderate to severe obstructive sleep apnea that is untreated or therapy non-compliant
- Operative: Previous prostate surgery or treatment procedure, including but not limited to BPH surgery, radiation, laser, prostate arterial embolism, balloon dilatation, or hyperthermic treatment, or prostate biopsy...
- Infection: Urinary tract infection (UTI) (105 CFU/mL) within 90 days of enrollment or \>3 UTIs within the year prior to enrollment.
- Incontinence: History of urinary incontinence.
- Retention: Requires indwelling catheter or intermittent catheterization to void or had an episode of spontaneous urinary retention within 30 days of enrollment.
- Prostatitis: History of prostatitis or chronic pelvic pain syndrome (CPPS) within 2 years of enrollment.
- Cystolithiasis: Active bladder stones
- Neurogenic bladder: Neurogenic or atonic bladder or sphincter, including etiologies of uncontrolled diabetes, Parkinson's disease, multiple sclerosis, cerebrovascular accident, or polyneuropathy.
- Anatomic abnormality: Prior or current urethral stricture, meatal stenosis, bladder neck contracture, or other urologic anatomic abnormalities that would interfere with planned treatment or confound subsequent...
- Implants: Any urinary tract implants including stents, sutures, penile implants, or artificial sphincters.
- Hematuria: Hematuria without a known contributing factor within 90 days of the Index Procedure.
- Bladder cancer: Actively being treated or suspected cancer of the bladder.
- Confirmed or history of prostate cancer
- Baseline PSA \> 15 ng/mL within 30 days of enrollment
- If PSA is between 4.0 ng/mL and 15 ng/mL, prostate cancer must be ruled out with a negative biopsy or an MRI (≤PIRADS-3) within 12 months prior to enrollment.
- Previous pelvic irradiation or radical pelvic surgery
- Previous rectal surgery (other than hemorrhoidectomy) or a history of rectal disease that may be impacted by Index Procedure.
- Peri-procedural anticoagulation: Unable to stop anti-platelet or anticoagulation treatment for the Index Procedure per site standard of care.
- i. Taking phenylephrine or pseudoephedrine within 24 hours of the Baseline evaluation and Index Procedure.
- i. Antihistamine, anticonvulsant, or antispasmodics medications within 1 week of enrollment unless documented on a stable (unchanged) dose for 180 days prior to enrollment.
- i. Use of alpha blockers or daily dosage of PDE5 inhibitors (tadalafil [Cialis]) for BPH within 2 weeks prior to enrollment.
- ii. Use of anticholinergics or beta-3 adrenergic receptor agonists (e.g., mirabegron, vibegron) within 2 weeks prior to enrollment, unless documented on a stable dose for 30 days prior to enrollment.
- i. Taking estrogen, drugs producing androgen suppression, or androgens within 90 days prior to enrollment, unless documented on a stable dosage for at least 180 days prior to enrollment.
- ii. Use of Type II 5-alpha reductase inhibitor medication (e.g., finasteride [Proscar, Propecia]) within 90 days of enrollment OR anticipated use within the first 12 months of follow-up.
- i. Use of any Type I 5-alpha reductase inhibitor medication (e.g., dutasteride [Avodart]) within 180 days prior to enrollment OR anticipate use within the first 12 months of follow-up.
- ii. Taking tricyclic antidepressants that are not on a stable dose for the 180 days prior to enrollment OR anticipate stopping or changing treatment in the first 12 months of follow-up.
- people who wish to maintain their fertility.
- Current or anticipated enrollment in any other assigned by chance or treatment clinical study (registry or retrospective studies permitted).
- Vulnerable populations, including individuals who are incarcerated or institutionalized.Any physical, psychological, or developmental impairment (e.g., developmental delay) that, in the investigator's opinion, would...
The study team makes the final eligibility decision.
Where it is enrolling
- Mesa, Arizona, United States
- Sun City, Arizona, United States
- Bakersfield, California, United States
- La Mesa, California, United States
- Sacramento, California, United States
- Lone Tree, Colorado, United States
- Tampa, Florida, United States
- Winter Garden, Florida, United States
- Meridian, Idaho, United States
- Lake Barrington, Illinois, United States
- Lafayette, Louisiana, United States
- Kearney, Nebraska, United States
- Plainview, New York, United States
- Germantown, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- West Lake Hills, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mesa, Arizona, United States; Sun City, Arizona, United States; Bakersfield, California, United States; La Mesa, California, United States; Sacramento, California, United States; Lone Tree, Colorado, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.