Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
NCT ID: NCT03123250
Last Updated: 2023-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2017-08-14
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aquablation procedure
Aquablation
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.
Interventions
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Aquablation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
80 Years
MALE
No
Sponsors
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PROCEPT BioRobotics
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Tibor Rubin VA Medical Center
Long Beach, California, United States
University of Southern California, Institute of Urology
Los Angeles, California, United States
San Diego Clinical Trials
San Diego, California, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Adult & Pediatrics Urology
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Vermont
Burlington, Vermont, United States
Virginia Urology
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
University of British Columbia
Vancouver, British Columbia, Canada
University of Toronto-University Health Network
Toronto, Ontario, Canada
Université de Montréal
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TP0124
Identifier Type: -
Identifier Source: org_study_id
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