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

PROCEPT BioRobotics

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: AquaBeam System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03125889

TP0131

Details and patient eligibility

About

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.

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 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.

Enrollment: 11 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Subjects will receive treatment with the AquaBeam System to remove prostatic tissue.

Treatment:

Device: AquaBeam System