Study NCT03123250
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)
Submitted Date:  September 23, 2021 (v12)
Quality Control Review Has Not Concluded

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Open or close this module Study Identification
Unique Protocol ID: TP0124
Brief Title: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)
Official Title: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2021
Overall Status: Active, not recruiting
Study Start: September 6, 2017
Primary Completion: March 27, 2018 [Actual]
Study Completion: March 2023 [Anticipated]
First Submitted: April 11, 2017
First Submitted that
Met QC Criteria:
April 20, 2017
First Posted: April 21, 2017 [Actual]
Results First Submitted: September 23, 2021
Results First Submitted that
Met QC Criteria:
Results First Posted: October 19, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: October 19, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: PROCEPT BioRobotics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Lower Urinary Tract Symptoms (LUTS)
AQUABEAM
Aquablation
Benign Prostatic Hyperplasia (BPH)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 101 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Aquablation procedure 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.
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. 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.
2. International Prostate Symptom Score Score Change
[ Time Frame: 3 months post-treatment ]

Change in total IPSS score at 3 months as compared to baseline.

International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.

Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 80 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Locations: United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
Tibor Rubin VA Medical Center
Long Beach, California, United States, 90822
University of Southern California, Institute of Urology
Los Angeles, California, United States, 90089
San Diego Clinical Trials
San Diego, California, United States, 92120
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Nebraska
Adult & Pediatrics Urology
Omaha, Nebraska, United States, 68114
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9110
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05054
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
University of Toronto-University Health Network
Toronto, Ontario, Canada, M5G 1Z6
Canada, Quebec
Université de Montréal
Montréal, Quebec, Canada, H2X 0A9
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: January 22, 2020
Uploaded: 03/12/2020 19:28
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: January 8, 2018
Uploaded: 03/12/2020 19:28
File Name: SAP_001.pdf

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Document Type or Document Date appear inconsistent with information in an uploaded study document.
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details
 
Arm/Group Title Aquablation Procedure
Arm/Group Description 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.
Period Title: Treatment
Started 101
Completed 101
Not Completed 0
Period Title: 1 Month Follow-Up
Started 101
Completed 101
Not Completed 0
Period Title: 3 Months Follow-Up
Started 101
Completed 98
Not Completed 3
Period Title: 6 Months Follow-Up
Started 99
Completed 99 [1]
Not Completed 0
[1]One subject, who had previously exited the study, was re-enrolled prior to the 6 months period.
Period Title: 12 Months Follow-Up
Started 99
Completed 96
Not Completed 3
Period Title: 24 Months Follow-Up
Started 96
Completed 86
Not Completed 10
Open or close this module Baseline Characteristics
Arm/Group TitleAquablation Procedure
Arm/Group DescriptionAquablation: 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.
Overall Number of Baseline Participants 101
Baseline Analysis Population Description [Not Specified]
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed101 Participants
67.5(6.6)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed101 Participants
Female
0
0%
Male
101
100%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed101 Participants
Hispanic or Latino
9
8.91%
Not Hispanic or Latino
92
91.09%
Unknown or Not Reported
0
0%
Race/Ethnicity, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed101 Participants
Race
Asian
5
4.95%
Black
6
5.94%
White
88
87.13%
Other
2
1.98%
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed101 Participants
Canada
19
United States
82
Body mass index
Mean (Standard Deviation)
Unit of measure: kg/m^2
Number Analyzed101 Participants
28.4(4.2)
Prostate size (TRUS)
Mean (Standard Deviation)
Unit of measure: cc
Number Analyzed101 Participants
107.4(22.1)
International Prostate Symptom Score (IPSS)
Mean (Standard Deviation)
Unit of measure: score on a scale
Number Analyzed101 Participants
23.2(6.3)
Open or close this module Outcome Measures
1. Primary Outcome:
Title Incidence of Clavien-Dindo Adverse Events
Description 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.
Time Frame 3 months post-treatment
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleAquablation Procedure
Arm/Group DescriptionAquablation: 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.
Overall Number of Participants Analyzed101
Measure Type: Number
Unit of Measure: percentage
45.5
2. Primary Outcome:
Title International Prostate Symptom Score Score Change
Description

Change in total IPSS score at 3 months as compared to baseline.

International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.

Time Frame 3 months post-treatment
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleAquablation Procedure
Arm/Group DescriptionAquablation: 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.
Overall Number of Participants Analyzed95
Number (95% Confidence Interval)
Unit of Measure: score on a scale
-16.5(-18.1 to -14.8)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Measure Type appears inaccurate.
Open or close this module Adverse Events
 
Time Frame 2 years
Adverse Event Reporting Description [Not specified]
 
Arm/Group Title Aquablation Procedure
Arm/Group Description 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.
All-Cause Mortality
  Aquablation Procedure
 Affected / At Risk (%)# Events
Total 0 / 101 (0%)
Serious Adverse Events
  Aquablation Procedure
 Affected / At Risk (%)# Events
Total 18 / 101 (17.82%)
Cardiac disorders
Cardiac 3 / 101 (2.97%)3
General disorders
Multi-system organ failure 1 / 101 (0.99%)1
Other 3 / 101 (2.97%)3
Nervous system disorders
Cerebrovascular accident 1 / 101 (0.99%)1
Renal and urinary disorders
Urinary incontinence 1 / 101 (0.99%)1
Urinary retention 1 / 101 (0.99%)1
Reproductive system and breast disorders
Scrotal edema 2 / 101 (1.98%)3
Surgical and medical procedures
Bleeding 9 / 101 (8.91%)9
Indicates events were collected by systematic assessment.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  Aquablation Procedure
 Affected / At Risk (%)# Events
Total 82 / 101 (81.19%)
General disorders
Other 14 / 101 (13.86%)
Pain 6 / 101 (5.94%)
Infections and infestations
Urinary tract infection 12 / 101 (11.88%)
Renal and urinary disorders
Dysuria 12 / 101 (11.88%)
Urinary incontinence 16 / 101 (15.84%)
Reproductive system and breast disorders
Ejaculatory dysfunction 23 / 101 (22.77%)
Surgical and medical procedures
Bleeding 8 / 101 (7.92%)
Indicates events were collected by systematic assessment.
Open or close this module Limitations and Caveats

Single arm study. Standardized event reporting categorized by CD grade limited in literature. Surgeon experience relatively limited. More experience likely to improve outcomes.

Longer follow-up needed to confirm results.

Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact:
Name/Official Title:
Angela Lee
Organization:
PROCEPT BioRobotics Corporation
Phone:
650-232-7215
Email:
a.lee@procept-biorobotics.com

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