ClinicalTrials.Veeva

Menu

Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (OPEN WATER)

P

PROCEPT BioRobotics

Status

Unknown

Conditions

BPH

Treatments

Procedure: Aquablation

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).

Enrollment

178 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male.
  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
  • Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
  • Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion criteria

  • Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
  • History of gross haematuria.
  • Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
  • Contraindication to both general and spinal anesthesia.
  • Any severe illness that would prevent complete study participation or confound study results.
  • Subject is unwilling to accept a transfusion should one be required.

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems