Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

NCT03123250 | Completed Results DMC FDA Device

• 1 other identifier: TP0124
• Study Type: interventional
• Target: 101
• Locations: 2 countries
• Sites: 16

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) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Lower Urinary Tract Symptoms (LUTS); AQUABEAM; Aquablation; Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (2)

• Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment

  The percentage 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.

  3 months post-treatment

• Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline

  The change in total IPSS score at 3 months as compared to baseline. The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.

  3 months post-treatment

Study Arms (1)

Aquablation procedure

EXPERIMENTAL

Device: Aquablation

Interventions

Aquablation DEVICE

The procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.

Aquablation procedure

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (16)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Tibor Rubin VA Medical Center

Long Beach, California, 90822, United States

Location

University of Southern California, Institute of Urology

Los Angeles, California, 90089, United States

Location

San Diego Clinical Trials

San Diego, California, 92120, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Adult & Pediatrics Urology

Omaha, Nebraska, 68114, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9110, United States

Location

University of Vermont

Burlington, Vermont, 05054, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of Toronto-University Health Network

Toronto, Ontario, M5G 1Z6, Canada

Location

Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (6)

• Bhojani N, Bidair M, Kramolowsky E, Desai M, Doumanian L, Zorn KC, Elterman D, Kaufman RP Jr, Eure G, Badlani G, Plante M, Uchio E, Gin G, Paterson R, So A, Roehrborn C, Motola J, Kaplan S, Humphreys M. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results. J Urol. 2023 Jul;210(1):143-153. doi: 10.1097/JU.0000000000003483. Epub 2023 Apr 28.

  PMID: 37115632 BACKGROUND

• Desai M, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Bhojani N. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU Int. 2019 Aug;124(2):321-328. doi: 10.1111/bju.14703. Epub 2019 Mar 29.

  PMID: 30734990 BACKGROUND

• Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys MR, Roehrborn CG, Kaplan S, Motola J, Zorn KC. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020 Apr;27(2):10147-10153.

  PMID: 32333733 BACKGROUND

• Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Zorn KC. WATER II (80-150 mL) procedural outcomes. BJU Int. 2019 Jan;123(1):106-112. doi: 10.1111/bju.14360. Epub 2018 Jun 10.

  PMID: 29694702 BACKGROUND

• Bhojani N, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Kaplan S, Motola J, Desai M, Roehrborn C. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019 Jul;129:1-7. doi: 10.1016/j.urology.2019.04.029. Epub 2019 May 3.

  PMID: 31059728 BACKGROUND

• Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5.

  PMID: 29873008 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Aquablation

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Limitations and Caveats

The main limitation is that the trial is a single-arm study with a pre-specified performance goal and not randomized against another treatment arm.

Results Point of Contact

• Title: Angela Lee
• Organization: PROCEPT BioRobotics Corporation

a.lee@procept-biorobotics.com

650-232-7215

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 21, 2017
• Study Start: August 14, 2017
• Primary Completion: March 27, 2018
• Study Completion: December 20, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Locations

US (13); CA (3)