PROCEPT AQUABEAM Study for the treatment of Benign Prostatic Hyperplasia (ABS)

PROCEPT BioRobotics Corporation0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•The target patient population is patients with symptomatic BPH who have not responded adequately to standard medical therapy.
•Inclusion Criteria
•b) Age 50 - 80 years
•c) Prostate size >= 25 g and <= 120 g
•d) IPSS score > 12
•e) Qmax <= 15ml/s
•f) History of inadequate response,contraindication or refusal to medical
•g) Patient is mentally capable and willingto sign a study-specific informed
•consent form
•h) Patient is willing and able to complywith all study requirements
•i) Schaffer scale >=Grade 2

•a) History of, current or suspected prostate/bladder cancer
•b) Elevated PSA (age 50-70 PSA >=4; age 70-80 PSA
•>=6.5) unless negative biopsy within last 3 months or positive biopsy
•c) Neurogenic bladder
•d) Prostatitis treated with antibiotics within 1 year of enrollment
•e) Current Urethral stricture, meatal stenosis, or bladder neck contracture
•f) Previous prostate surgery
•g) Significant Renal impairment
•h) Active infection, including urinary tract infection
•i) Patients on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy
•j) Gross haematuria
•k) Known allergy to device materials
•l) Any severe illness that would prevent complete study participation or confound study results
•m) Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure â?? NYHA Class IV), pulmonary disease or uncontrolled diabetes.
•n) Participants using immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents(NSAIDs, including
•aspirin) for 14 days prior to treatment; Known illicit substance abuse
•o) Dementia or psychiatric condition that prevents the participant from completing required follow up
•p) Contraindication to general anesthesia
•q) Participating in another investigational study that could affect responses to the study device

发起方