Acute Hemostasis following the use of the AQUABEAMÂ® Systemfor the treatment of Benign Prostatic Hyperplasia III - AHAIII

PROCEPT BioRobotics0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
•2. Prostate size >= 50 mL and <= 150 mL
•3. IPSS score ï?³ 12
•4. Qmax <= 15ml/s
•5. History of inadequate response, contraindication to or refusal of medical therapy
•6. Patient is mentally capable and willing to sign a study-specific informed consent form
•7. Patient is willing and able to comply with all study requirements

•1. BMI >= 42
•2. Prostatitis treated with antibiotics within 1 year of enrollment
•3. Significant renal impairment
•4. Active infection, including urinary tract infection
•5. Patients on anticoagulants (if medication cannot be stopped 5 days before and after procedure) or known coagulopathy or platelet disorder (except aspirin below 100mg/d)
•6. History of gross haematuria
•7. Known allergy to device materials, porcine gelatin, or materials of bovine origin
•8. Any severe illness that would prevent complete study participation or confound study results
•9. 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.
•10. Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
•11. ASA III or higher
•12. Participants using systemic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) for 14 days prior to treatment
•13. Known illicit substance abuse
•14. Dementia or psychiatric condition that prevents the participant from completing required follow up
•15. Contraindication to both general and spinal anesthesia
•16. Participating in another investigational study that could affect responses to the study device
•17. Subject is unwilling to accept a transfusion should one be required

发起方

PROCEPT BioRobotics