AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia (ABS)

PROCEPT BioRobotics

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: AquaBeam System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03167294

TP0032

Details and patient eligibility

About

Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia

Enrollment: 47 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• 50 - 80 years
• Moderate to severe BPH
• Subjects who have failed standard medical therapy

Exclusion criteria

• Size and width of prostate
• Medical condition or co-morbidities where BPH intervention would be contraindicated

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Single Arm

Other group

Description:

AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH

Treatment:

Device: AquaBeam System