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Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)

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: NCT03123250
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
PROCEPT BioRobotics

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE September 6, 2017
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Incidence of Clavien-Dindo Adverse Events [ Time Frame: 3 months post-treatment ]
    Proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.
  • International Prostate Symptom Score score change [ Time Frame: 3 months post-treatment ]
    Change in total IPSS score at 3 months as compared to baseline
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 Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Official Title  ICMJE Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Brief Summary Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 36 months to collect long-term clinical data.
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: Aquablation
To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
Study Arms  ICMJE Experimental: Aquablation procedure
Intervention: Device: Aquablation
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 8, 2018)
101
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
100
Estimated Study Completion Date  ICMJE March 2021
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male age 45-80 years.
  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
  • Subject has an IPSS score greater than or equal to 12.
  • Maximum urinary flow rate (Qmax) less than 15mL/s.
  • Serum creatinine < 2 mg/dL within 30 days of surgery.
  • History of inadequate or failed response, contraindication, or refusal to medical therapy.
  • Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.
  • Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion Criteria:

  • BMI ≥ 42.
  • Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
  • Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
  • Contraindication to both general and spinal anesthesia.
  • Any severe illness that would prevent complete study participation or confound study results.
  • History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.
  • History of actively treated bladder cancer within the past two (2) years.
  • Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size >20% of full bladder size).
  • Active infection, including urinary tract infection or prostatitis.
  • Urinary catheter use daily for 90 or more days consecutively.
  • Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
  • Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
  • Known damage to external urinary sphincter.
  • Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent.
  • Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
  • 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03123250
Other Study ID Numbers  ICMJE TP0124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party PROCEPT BioRobotics
Study Sponsor  ICMJE PROCEPT BioRobotics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PROCEPT BioRobotics
Verification Date August 2019

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