Health Condition 1: null- Patients suffering from Lower Urinary Tract Symptoms (LUTS) and bladder outlet obstruction (BOO) as a result of Benign Prostatic Hyperplasia (BPH)
Conditions
Interventions
Intervention1: AquaBeam System,
Commercially Approved Catheters: Subjects will be treated with the AquaBeam System to remove enlarged prostatic tissue. Following treatment with the device, a urinary c
Sponsors
PROCEPT BioRobotics
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male 2. Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction 3. Age from 40 through 85 years 4. Prostate size >= 20 ml and 5. IPSS score >= 12 6. Qmax 7. History of inadequate response, contraindication to or refusal of medical therapy 8. Patient is mentally capable and willing to sign a study-specific informed consent form 9. Patient is willing and able to comply with all study requirements
Exclusion criteria
Exclusion criteria: 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects that require electrocautery or any other intervention post 3-way Coleman Balloon Foley (or equivalent) Catheter removal.Timepoint: Baseline through Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Prostate Volume from BaselineTimepoint: Baseline and 1 Week;Additional exploratory analysis may be performed as necessaryTimepoint: Baseline through subject study exit;Blood loss as measured by a HemoCue PhotometerTimepoint: intraoperatively through catheter insertion, and during recover while 3-way catheter is in place;Change from baseline in IPSSTimepoint: Baseline and 1 Week;Change in Hemoglobin ConcentrationTimepoint: Baseline, Pre-Op, Post-Op, 1-Week;Fluid usageTimepoint: Intraoperative and Post-Operative;Procedure DurationTimepoint: Index Procedure;Time of Discharge Readiness as based on a "Discharge Readiness Scale"Timepoint: Recovery through Discharge;Urinary Flow Rate (Qmax) and Post-Void Residual VolumeTimepoint: Baseline and at 1-Week | — |
Countries
India
Contacts
Public ContactJanki Chauhan
Muljibhai Patel Urological Hospital
Outcome results
None listed