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

NCT04308070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-03-13

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

AQUABEAM 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.

DEVICE

AQUABEAM 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 & Collaborators

  • PROCEPT BioRobotics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2018-03-22
Completion
2018-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308070 on ClinicalTrials.gov