A Pilot Study of the ALPFA BPH PFA System in Men with Symptomatic Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This is a prospective, open-label, single-arm clinical study to evaluate the safety and feasibility of a catheter-based medical device for the treatment of benign prostatic hyperplasia in men with lower urinary tract symptoms. Male participants aged 45 years and above with persistent urinary symptoms despite prior medical therapy for benign prostatic hyperplasia will be screened for eligibility. After providing written informed consent, eligible participants will be enrolled in the study. Enrolled participants will undergo a single transurethral pulsed field ablation procedure performed under cystoscopic guidance. During the procedure, controlled electrical pulses are delivered through a catheter-based system to ablate targeted prostate tissue. Treatment settings and catheter positioning are determined by the investigator based on cystoscopic assessment of the prostatic urethra. Following the procedure, participants will be monitored for device- and procedure-related adverse events. Follow-up visits will be conducted at predefined intervals, including early and long-term assessments, up to 360 days after treatment. Study evaluations include assessment of safety outcomes, changes in urinary symptoms using validated symptom scores, urinary flow parameters, post-void residual urine volume, prostate-related laboratory parameters, quality of life measures, and sexual function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients who are greater than equal to 45 years of age on the day of enrollment.
- •Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication.
- •Patients with symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s): a.
- •Symptom Score: a baseline IPSS score of 13 or greater.
排除标准
- •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: a.
- •Unstable cardiovascular disease including: i.
- •NYHA III/IV heart failure or LVEF less than 40% ii.
- •Uncontrolled arrhythmia iii.
- •Stroke, TIA, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment.
- •Uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 95 mmHg on two (2) BP measurements taken at least 3 minutes apart at baseline assessment).
- •Renal: Serum creatinine greater than 1.8 or any history of renal dialysis or renal transplant c.
- •Nonurologic cancer: Active malignancy (other than cutaneous basal cell or squamous cell carcinoma d.
- •Metabolic: clinically uncontrolled diabetes mellitus or a baseline HbA1c greater than equal to 8.0%, or clinically significant liver disease e.
- •Respiratory: Any lung disease involving abnormal blood gases or significant dyspnea f.
- •Infection: active systemic infection g.
- •Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy.
- •Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis.
- •Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant j.
- •Active 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: a.
- •Previous operative intervention for BPH b.
- •Active urinary tract infection (may be treated and enrolled upon negative urine culture).
- •Incontinence: catheter dependent or had an episode of spontaneous urinary retention within 90 days of enrollment.
- •Prostatitis: a history of any prostatitis within 2 years of enrollment.
- •Cystolithiasis active within 90 days of enrollment f.
- •Neurogenic bladder: neurogenic or atonic bladder, including etiologies of uncontrolled diabetes, Parkinson’s disease, multiple sclerosis, stroke/TIA 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 assessment (potentially an intra-procedural exclusion).
- •Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer.
- •Prostate cancer: a.
- •Known or clinically suspected prostate cancer b.
- •A PSA value greater than 10 ng/ml c.
研究者
Dr Sanjay Balwant Kulkarni
Urokul Hospital