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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 13, 2017
First Posted Date  ICMJE June 19, 2017
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE September 19, 2017
Actual Primary Completion Date July 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
AQUABEAM System Effectiveness: IPSS total score change [ Time Frame: 6 Months Post-op ]
IPSS total score change from baseline to 6 Month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Official Title  ICMJE French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia (BPH)
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: AQUABEAM System
AQUABEAM System
Intervention: Device: AQUABEAM System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 7, 2019
Actual Primary Completion Date July 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03191734
Other Study ID Numbers  ICMJE TP0112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party PROCEPT BioRobotics
Study Sponsor  ICMJE PROCEPT BioRobotics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aurelien Descazeaud, MD Centre Hospitalier Régional Universitaire de Limoges
PRS Account PROCEPT BioRobotics
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP