AQUABEAM® Robotic System and Ultrasound Accessories

NCT05157529 | Recruiting FDA Device

• 1 other identifier: 2022-10283
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and severe LUTS is 20 - 25% (Hunter et al. 1994). The complaints are potentially associated with a considerable impairment of the quality of life (Trueman et al. 1999). LUTS in older men are commonly caused by a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE). The histological term "benign prostatic hyperplasia" (BPH) is frequently used in literature and clinical practice as a synonym for this diagnosis. Surgical therapy of BPH has continuously evolved in recent years. One of the latest technologies for transurethral prostate desobstruction is the Aquablation therapy, first described in 2015 (AQUABEAM®, PROCEPT BioRobotics, Redwood Shores, CA, USA) (Faber et al 2015). The AQUABEAM Robotic System is the first and only image-guided, heat-free robotic therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is designed for cutting of prostate tissue during a minimally invasive surgical procedure. Once inserted via a transurethral approach and advanced through the urethra and into the prostatic urethra, the device applies an ultrasound-guided water jet that precisely ablates the prostate tissue. Aquablation therapy is unique in that it combines cystoscopic visualization, ultrasound imaging and advanced planning software to provide the surgeon with a multidimensional view of the treatment area. This enables personalized treatment planning for the patient's unique anatomy, improved decisionmaking and real-time monitoring during the procedure. This prospective single-arm investigational clinical trial aims at assessing the efficacy and safety of the new generation of the AQUABEAM Robotic System (P1G3) and the Apogee 2300 Ultrasound System and compare the percentage of patients who are discharged the day of the surgery among different groups of BPH patients who undergo aquablation using the third generation of the AQUABEAM Robotic System.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

• The change of the International Prostate Symptom Score (IPSS) from baseline to 3 months

  The International Prostate Symptom Score (IPSS) change from baseline to 3 months will be compared to an objective performance criterion (OPC) based upon published TURP results of 16 points. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

  3 months

• Rate of Unanticipated Serious Adverse Effect (USADE)

  Unanticipated Serious Adverse Effect (USADE) rate observed up to the 3 months follow-up visit.

  Immediately after the surgery

Secondary Outcomes (1)

• Identification of the anatomical landmarks

  Immediately after the surgery

Other Outcomes (5)

• Percentage of study subjects who were discharged on the day of surgery

  Immediately after the surgery

• Post-op catheterization duration

  3 months

• Rate of readmissions within 1 week of discharge

  1 week

Study Arms (1)

Aquablation

EXPERIMENTAL

The participant will undergo aquablation procedure for Benign Prostate Hypeplasia (BPH) treatment using the AQUABEAM Robotic System and Ultrasound Accessories

Device: AQUABEAM Robotic System; Device: Apogee 2300 digital color doppler ultrasound imaging system

Interventions

AQUABEAM Robotic System DEVICE

The AQUABEAM Robotic System is developed and manufactured by PROCEPT BioRobotics, Corp. It is intended for use in patients suffering from lower urinary tract (LUTS) resulting from benign prostatic hyperplasia (BPH). The AQUABEAM Robotic System is designed for cutting of prostate tissue during minimally invasive surgical procedure and shall be inserted via transurethral approach and is advanced through the urethra and into the prostatic urethra. The system is designed to utilize a high-velocity sterile saline stream as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly motion is driven by a motor system, controlled by the user. The pressure is generated by a high-velocity pump system controlled by the AQUABEAM Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on a medical panel computer. Pre-condition parameters are set on the console before operation.

Aquablation

Apogee 2300 digital color doppler ultrasound imaging system DEVICE

The SIUI Apogee 2300 is a digital ultrasound imaging system capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM). The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

Aquablation

Eligibility Criteria

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

You may qualify if:

• a) Patient has diagnosis of LUTS due to BPH
• b) Patient is mentally capable and willing to sign a study-specific informed consent form
• c) Patient is able and willing to follow study instructions and likely to attend and complete all required study visits

You may not qualify if:

• a) Patient is 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
• b) Contraindications for general and spinal anesthesia
• c) Patient is unwilling to accept a blood transfusion if required

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• PROCEPT BioRobotics: collaborator

Study Sites (1)

Centre Hospitalier de l'université de Montréal (CHUM)

Montreal, Quebec, QC H2X 0A9, Canada

RECRUITING

Related Publications (15)

• Hunter DJ, McKee CM, Black NA, Sanderson CF. Urinary symptoms: prevalence and severity in British men aged 55 and over. J Epidemiol Community Health. 1994 Dec;48(6):569-75. doi: 10.1136/jech.48.6.569.

  PMID: 7830011 BACKGROUND

• Trueman P, Hood SC, Nayak US, Mrazek MF. Prevalence of lower urinary tract symptoms and self-reported diagnosed 'benign prostatic hyperplasia', and their effect on quality of life in a community-based survey of men in the UK. BJU Int. 1999 Mar;83(4):410-5. doi: 10.1046/j.1464-410x.1999.00966.x.

  PMID: 10210562 BACKGROUND

• Roehrborn CG, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Herron S, Rashid P, Rukstalis DB. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802-8813.

  PMID: 28646935 BACKGROUND

• Gratzke C, Barber N, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Patterson JM, Fahrenkrug L, Schoenthaler M, Sonksen J. Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJU Int. 2017 May;119(5):767-775. doi: 10.1111/bju.13714. Epub 2016 Dec 21.

  PMID: 27862831 BACKGROUND

• Faber K, de Abreu AL, Ramos P, Aljuri N, Mantri S, Gill I, Ukimura O, Desai M. Image-guided robot-assisted prostate ablation using water jet-hydrodissection: initial study of a novel technology for benign prostatic hyperplasia. J Endourol. 2015 Jan;29(1):63-9. doi: 10.1089/end.2014.0304.

  PMID: 25000418 BACKGROUND

• Gilling P, Reuther R, Kahokehr A, Fraundorfer M. Aquablation - image-guided robot-assisted waterjet ablation of the prostate: initial clinical experience. BJU Int. 2016 Jun;117(6):923-9. doi: 10.1111/bju.13358. Epub 2015 Nov 19.

  PMID: 26477826 BACKGROUND

• Bach T, Giannakis I, Bachmann A, Fiori C, Gomez-Sancha F, Herrmann TRW, Netsch C, Rieken M, Scoffone CM, Tunc L, Rassweiler JJ, Liatsikos E. Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort. World J Urol. 2019 Jul;37(7):1369-1375. doi: 10.1007/s00345-018-2509-y. Epub 2018 Oct 4.

  PMID: 30288598 BACKGROUND

• Gilling P, Anderson P, Tan A. Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results. J Urol. 2017 Jun;197(6):1565-1572. doi: 10.1016/j.juro.2017.01.056. Epub 2017 Jan 20.

  PMID: 28111300 BACKGROUND

• Misrai V, Rijo E, Zorn KC, Barry-Delongchamps N, Descazeaud A. Waterjet Ablation Therapy for Treating Benign Prostatic Obstruction in Patients with Small- to Medium-size Glands: 12-month Results of the First French Aquablation Clinical Registry. Eur Urol. 2019 Nov;76(5):667-675. doi: 10.1016/j.eururo.2019.06.024. Epub 2019 Jul 5.

  PMID: 31281024 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

• Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation(R) vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. J Urol. 2018 May;199(5):1252-1261. doi: 10.1016/j.juro.2017.12.065. Epub 2018 Jan 31.

  PMID: 29360529 BACKGROUND

• Plante M, Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial. BJU Int. 2019 Apr;123(4):651-660. doi: 10.1111/bju.14426. Epub 2018 Jul 26.

  PMID: 29862630 BACKGROUND

• Sorokin I, Sundaram V, Singla N, Walker J, Margulis V, Roehrborn C, Gahan JC. Robot-Assisted Versus Open Simple Prostatectomy for Benign Prostatic Hyperplasia in Large Glands: A Propensity Score-Matched Comparison of Perioperative and Short-Term Outcomes. J Endourol. 2017 Nov;31(11):1164-1169. doi: 10.1089/end.2017.0489. Epub 2017 Sep 26.

  PMID: 28854815 BACKGROUND

• Monn MF, El Tayeb M, Bhojani N, Mellon MJ, Sloan JC, Boris RS, Lingeman JE. Predictors of Enucleation and Morcellation Time During Holmium Laser Enucleation of the Prostate. Urology. 2015 Aug;86(2):338-42. doi: 10.1016/j.urology.2015.04.028. Epub 2015 Jul 15.

  PMID: 26189134 BACKGROUND

• TY - JOUR AU - Desai, Mihir AU - Bidair, Mo AU - Bhojani, Naeem AU - Trainer, Andrew AU - Arther, Andrew AU - Kramolowsky, Eugene AU - Doumanian, Leo AU - Elterman, Dean AU - Jr, Ronald AU - Lingeman, James AU - Krambeck, Amy AU - Eure, Gregg AU - Badlani, Gopal AU - Plante, Mark AU - Uchio, Edward AU - Gin, Greg AU - Goldenberg, Larry AU - Paterson, Ryan AU - So, Alan AU - Zorn, Kevin PY - 2018/04/01 SP - T1 - Aquablation Procedural Outcomes for BPH in Large Prostates (80-150cc): Initial Experience VL - 123 DO - 10.1111/bju.14360 JO - BJU International ER -

  RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

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

Study Officials

• Naeem Bhojani, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naeem Bhojani, MD

CONTACT

514-890-8000; naeem.bhojani@gmail.com

Kahina Bensaadi, DESS

CONTACT

514-890-8000; kahina.bensaadi.chum@ssss.gouv.qc.ca

Study Design

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

Model Details: Prospective single-arm investigational clinical trial assessing the efficacy and safety of the new generation of the AQUABEAM Robotic System (P1G3) and the Apogee 2300 Ultrasound System.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 15, 2021
• Study Start: February 16, 2023
• Primary Completion: April 15, 2024
• Study Completion: December 30, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)