Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

BPH Clinical Trial

— OPEN WATER  

Official title:

Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02974751
• Other study ID #: TP0118
• Status: Active, not recruiting
• Start date: September 5, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: October 2019
• Source: PROCEPT BioRobotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: February 29, 2020
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• BPH

Intervention

Procedure:
• Aquablation
Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Germany	Asklepios Klinikum Harburg	Hamburg
Lebanon	American University of Beirut Medical Center	Beirut
New Zealand	Tauranga Urology Research	Tauranga
United Kingdom	Frimley Park Hospital	Frimley	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
PROCEPT BioRobotics

Countries where clinical trial is conducted

Australia,  Germany,  Lebanon,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS score change		3 months