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

P

PROCEPT BioRobotics

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: AquaBeam System

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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