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

Sponsor
PROCEPT BioRobotics (Industry)
Overall Status
Completed
CT.gov ID
NCT03191734
Collaborator
(none)
30
Enrollment
3
Locations
1
Arm
15.6
Actual Duration (Months)
10
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AQUABEAM System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Actual Study Start Date :
Sep 19, 2017
Actual Primary Completion Date :
Jul 2, 2018
Actual Study Completion Date :
Jan 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: AQUABEAM System

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.

Outcome Measures

Primary Outcome Measures

  1. AQUABEAM System Effectiveness: IPSS total score change [6 Months Post-op]

    IPSS total score change from baseline to 6 Month

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Limoges Limoges France 87042
2 Hôpital Cochin Paris France 75014
3 Clinique Pasteur Toulouse France 31300

Sponsors and Collaborators

  • PROCEPT BioRobotics

Investigators

  • Principal Investigator: Aurelien Descazeaud, MD, Centre Hospitalier Régional Universitaire de Limoges

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PROCEPT BioRobotics
ClinicalTrials.gov Identifier:
NCT03191734
Other Study ID Numbers:
  • TP0112
First Posted:
Jun 19, 2017
Last Update Posted:
Feb 22, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PROCEPT BioRobotics
Lower Urinary Tract Symptoms (LUTS)
Benign Prostatic Hyperplasia (BPH)
AQUABEAM
Aquablation
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia

Study Results

No Results Posted as of Feb 22, 2019