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

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ClinicalTrials.gov Identifier: NCT03191734
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
PROCEPT BioRobotics

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
Benign Prostatic Hyperplasia (BPH) Device: AQUABEAM System Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 19, 2017
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : January 7, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. AQUABEAM System Effectiveness: IPSS total score change [ Time Frame: 6 Months Post-op ]
    IPSS total score change from baseline to 6 Month



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191734


Locations
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France
CHU de Limoges
Limoges, France, 87042
Hôpital Cochin
Paris, France, 75014
Clinique Pasteur
Toulouse, France, 31300
Sponsors and Collaborators
PROCEPT BioRobotics
Investigators
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Principal Investigator: Aurelien Descazeaud, MD Centre Hospitalier Régional Universitaire de Limoges
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Responsible Party: PROCEPT BioRobotics
ClinicalTrials.gov Identifier: NCT03191734    
Other Study ID Numbers: TP0112
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases