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OpenTrials
Completed

NCT Number: NCT03167294

AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

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

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, 387001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AQUABEAM System

Device

Aquablation

Primary outcomes

  1. Primary Device Performance Endpoint

    Time frame: 6 months

    The primary device performance endpoint is completion of the intended surgical procedure.

  2. Primary Safety Endpoint of the study is the perioperative complication rate.

    Time frame: 6 months

    The primary safety endpoint of the study is the perioperative complication rate

Sponsors and collaborators

Lead sponsor

PROCEPT BioRobotics

Industry

Registry information

Official study title

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

Acronym: ABS

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 25, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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