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

NCT04308070 | Completed

• 1 other identifier: TP0148
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Image-guided; BPH; Aquablation; AQUABEAM; LUTS; Tissue resection; Robotics

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  7 days post-op

Study Arms (2)

Catheter without Hemostatic Agent Following Aquablation

EXPERIMENTAL

AQUABEAM System followed by catheter without hemostatic agent

Device: AQUABEAM System followed by catheter without hemostatic agent

Catheter with Hemostatic Agent Following Aquablation

EXPERIMENTAL

AQUABEAM System followed by catheter with hemostatic agent

Device: AQUABEAM System followed by catheter with hemostatic agent

Interventions

AQUABEAM System followed by catheter without hemostatic agent DEVICE

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.

Catheter without Hemostatic Agent Following Aquablation

AQUABEAM System followed by catheter with hemostatic agent DEVICE

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.

Catheter with Hemostatic Agent Following Aquablation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• BPH symptoms

You may not qualify if:

• Serious concurrent medical conditions

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (1)

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, 387001, India

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: March 13, 2020
• Study Start: July 18, 2017
• Primary Completion: March 22, 2018
• Study Completion: June 30, 2018
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

IN (1)