WATERII: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Sponsor

PROCEPT BioRobotics (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03123250

Collaborator

(none)

101

Enrollment

Locations

Arm

41.8

Anticipated Duration (Months)

6.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia (BPH)	Device: Aquablation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Actual Study Start Date :

Sep 6, 2017

Actual Primary Completion Date :

Mar 27, 2018

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Incidence of Clavien-Dindo Adverse Events [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 [3 months post-treatment]
Change in total IPSS score at 3 months as compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	Tibor Rubin VA Medical Center	Long Beach	California	United States	90822
3	University of Southern California, Institute of Urology	Los Angeles	California	United States	90089
4	San Diego Clinical Trials	San Diego	California	United States	92120
5	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
6	Adult & Pediatrics Urology	Omaha	Nebraska	United States	68114
7	Albany Medical College	Albany	New York	United States	12208
8	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
9	Wake Forest School of Medicine	Winston-Salem	North Carolina	United States	27157
10	UT Southwestern Medical Center	Dallas	Texas	United States	75390-9110
11	University of Vermont	Burlington	Vermont	United States	05054
12	Virginia Urology	Richmond	Virginia	United States	23235
13	Urology of Virginia	Virginia Beach	Virginia	United States	23462
14	University of British Columbia	Vancouver	British Columbia	Canada	V5Z 1M9
15	University of Toronto-University Health Network	Toronto	Ontario	Canada	M5G 1Z6
16	Université de Montréal	Montréal	Quebec	Canada	H2X 0A9