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

PROCEPT BioRobotics

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: AquaBeam System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03125863

TP0113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Subjects will receive treatment with the AquaBeam System to remove enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis.

Treatment:

Device: AquaBeam System