Trials / Completed
CompletedNCT03125863
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- PROCEPT BioRobotics · Industry
- Sex
- Male
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters 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 Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AquaBeam System | The AquaBeam system delivers a high-velocity 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 AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone. |
Timeline
- Start date
- 2016-08-26
- Primary completion
- 2016-09-03
- Completion
- 2017-07-31
- First posted
- 2017-04-24
- Last updated
- 2017-11-14
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT03125863. Inclusion in this directory is not an endorsement.