Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT03125889
- Lead Sponsor
- PROCEPT BioRobotics
- Brief Summary
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis following prostate resection using the AQUABEAM for treatment of LUTS resulting from BPH.
- Detailed Description
PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The AQUABEAM System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 30 days for safety assessment prior to study exit. The trial is a single-arm prospective, interventional clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 11
- Male
- BPH symptoms
- Serious concurrent medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Completion of the intended surgical procedure with adequate hemostasis 7 days post-op Proportion of subjects who return to the OR for bleeding treatment or requires transfusion 7 days post-op
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Muljibhai Patel Urological Hospital
🇮🇳Nadiad, Gujarat, India
Muljibhai Patel Urological Hospital🇮🇳Nadiad, Gujarat, India