AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03167294

Acronym

ABS

Enrollment

Registered

2017-05-25

Start date

2014-12-14

Completion date

2017-04-27

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Aquablation, AQUABEAM, BPH, LUTS

Brief summary

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

Interventions

DEVICEAquaBeam System

Aquablation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Device Performance Endpoint	6 months	The primary device performance endpoint is completion of the intended surgical procedure.
Primary Safety Endpoint of the study is the perioperative complication rate.	6 months	The primary safety endpoint of the study is the perioperative complication rate

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026