French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: AQUABEAM System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU de Limoges
  • Paris, France, 75014
    • Hôpital Cochin
  • Toulouse, France, 31300
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
• History of inadequate response, contraindication or refusal to medical therapy for BPH.
• Age from 45 through 80 years.
• Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline.

Exclusion Criteria:

• BMI ≥ 42.
• IPSS total score <12.
• History of prostate cancer or clinically significant elevated PSA value.
• History of bladder cancer actively treated within 2 years prior to the surgical procedure.
• Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
• Active infection, including urinary tract infection within 72 hours of the treatment procedure.
• Prostatitis treated with antibiotics within 1 year of the surgical procedure.
• Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter.
• Subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
• Clinically significant abnormal serum creatinine measured within 30 days of treatment.
• Maximum urinary flow rate (Qmax) >15 mL/s or PVR > 300 mL measured by uroflowmetry test at baseline.
• Subject has been catheterized due to retention within 14 days prior to the surgical procedure.
• Subject has a history of intermittent self-catheterization.
• Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis
• Subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d)
• Any severe illness or psychiatric condition that would prevent study completion or confound study results.
• Subject taking systemic immune-suppressants including corticosteroids; unable to withhold non- steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than 100mg).
• Participants using medications specifically for bladder muscle problems (e.g., irritability). Use of medications with anticholinergic or similar properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
• Participating in another investigational study that could affect responses to the study device.
• Subject is unwilling to accept a transfusion should one be required.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AQUABEAM System	Device: AQUABEAM System; Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AQUABEAM System Effectiveness: IPSS total score change	IPSS total score change from baseline to 6 Month	6 Months Post-op

Collaborators and Investigators

• Sponsor: PROCEPT BioRobotics
• Investigators: Principal Investigator: Aurelien Descazeaud, MD, Centre Hospitalier Régional Universitaire de Limoges

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): July 2, 2018
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS); Aquablation; AQUABEAM
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: TP0112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No