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NCT03125889 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

— AHA II  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03125889
Other study ID # TP0131
Secondary ID
Status Completed
Phase N/A
First received March 14, 2017
Last updated November 10, 2017
Start date April 10, 2017
Est. completion date July 7, 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 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 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 information / eligibility
Status Completed
Enrollment 11
Est. completion date July 7, 2017
Est. primary completion date April 18, 2017
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- Male

- BPH symptoms

Exclusion Criteria:

- Serious concurrent medical conditions

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 with adequate hemostasis 7 days post-op
Primary Proportion of subjects who return to the OR for bleeding treatment or requires transfusion 7 days post-op
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