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NCT03125863 Clinical Trial

Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

— AHA  

Official title:
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03125863
Other study ID # TP0113
Secondary ID
Status Completed
Phase N/A
First received August 9, 2016
Last updated November 10, 2017
Start date August 26, 2016
Est. completion date July 31, 2017

Study information
Verified date November 2017
Source PROCEPT BioRobotics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 31, 2017
Est. primary completion date September 3, 2016
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- Male age from 40 through 85 years with LUTS due to BPH

Exclusion Criteria:

- Any severe illness that would prevent complete study participation or confound study results

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
India Muljibhai Patel Urological Hospital Nadiad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
PROCEPT BioRobotics

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Completion of the intended surgical procedure 7 days post-op
Primary Proportion of subjects that require electrocautery or any other intervention post catheter removal. 7 days post-op
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