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

NCT03191734 | Completed

• 1 other identifier: TP0112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Lower Urinary Tract Symptoms (LUTS); Benign Prostatic Hyperplasia (BPH); AQUABEAM; Aquablation

Outcome Measures

Primary Outcomes (1)

• AQUABEAM System Effectiveness: IPSS total score change

  IPSS total score change from baseline to 6 Month

  6 Months Post-op

Study Arms (1)

AQUABEAM System

EXPERIMENTAL

AQUABEAM System

Device: AQUABEAM System

Interventions

AQUABEAM System DEVICE

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.

AQUABEAM System

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (3)

CHU de Limoges

Limoges, 87042, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aurelien Descazeaud, MD

  Centre Hospitalier Régional Universitaire de Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: September 19, 2017
• Primary Completion: July 2, 2018
• Study Completion: January 7, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

FR (3)