Health Condition 1: null- Benign Prostatic Hyperplasia
Conditions
Interventions
Intervention1: PROCEPT AQUABEAM® System: The AQUABEAM® System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms.
Control Intervention1
Sponsors
PROCEPT BioRobotics Corporation
JSS Medical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: The target patient population is patients with symptomatic BPH who have not responded adequately to standard medical therapy. Inclusion Criteria a) Male b) Age 50 - 80 years c) Prostate size >= 25 g and d) IPSS score > 12 e) Qmax f) History of inadequate response,contraindication or refusal to medical therapy 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Device performance outcome: â?¢ Completion of the intended surgical procedure Primary Safety outcome: â?¢ Peri-operative complication rate. Timepoint: On the day of surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional outcomes include: â?¢ Proportion of subjects and period of Foley catheter placement postoperatively: Baseline and 1 week â?¢ Change in prostate volume at 6 months â?¢ Additional exploratory analysis may be performed as necessary: Baseline and 12 months Timepoint: Baseline and 1 week, 6 months, Baseline and 12 months;â?¢ Change from baseline in International Prostate System Score, International Index of Erectile Function.Timepoint: From baseline to study completion. Also includes one unscheduled visit: Baseline and 12 months ;â?¢ Change from baseline in peak urinary flow rate, post-void residual volume and PDet@Qmax (Schaffer grade)Timepoint: Baseline and 6 months. | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed