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

PROCEPT BioRobotics

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: AQUABEAM System followed by catheter with hemostatic agent; Device: AQUABEAM System followed by catheter without hemostatic agent

Study type: Interventional

Funder types: Industry

Identifiers

NCT04308070

TP0148

Details and patient eligibility

About

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.

Full description

PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents 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 3 months for safety assessment prior to study exit. The trial is a dual-arm prospective, interventional clinical trial.

Enrollment: 26 patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• BPH symptoms

Exclusion criteria

• Serious concurrent medical conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Catheter without Hemostatic Agent Following Aquablation

Experimental group

Description:

AQUABEAM System followed by catheter without hemostatic agent

Treatment:

Device: AQUABEAM System followed by catheter without hemostatic agent

Catheter with Hemostatic Agent Following Aquablation

Experimental group

Description:

AQUABEAM System followed by catheter with hemostatic agent

Treatment:

Device: AQUABEAM System followed by catheter with hemostatic agent