Benign Prostatic Hyperplasia
Conditions
Keywords
Image-guided, BPH, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics
Brief summary
A dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the AQUABEAM System.
Detailed description
PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents 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 3 months for safety assessment prior to study exit. The trial is a dual-arm prospective, interventional clinical trial.
Interventions
DEVICEAQUABEAM System followed by catheter without hemostatic agent
The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter to achieve hemostasis post-Aquablation procedure.
DEVICEAQUABEAM System followed by catheter with hemostatic agent
The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter with hemostatic agent to achieve hemostasis post-Aquablation procedure.
Sponsors
PROCEPT BioRobotics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male * BPH symptoms
Exclusion criteria
* Serious concurrent medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects that do not require a transfusion and do not return to the operating room for hematuria management within 7 days following the index procedure. | 7 days post-op | Adequate hemostasis post-Aquablation with the use of a urinary catheter and / or delivery of a hemostatic agent, measured by the number of subjects that, within 7 days following the index procedure, do not require a transfusion and do not return to the operating room for hematuria management. |
Countries
India
Outcome results
None listed