Comparison of Holmium Laser and Thulium Laser for Mini PCNL

NCT06266793 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 2072488-2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting.

Conditions

Nephrolithiasis; Percutaneous Nephrolithotomy

Keywords

Laser; Holmium laser; Thulium fiber laser; PCNL; Nephrolithiasis; Percutaneous Nephrolithotomy

Outcome Measures

Primary Outcomes (1)

• Laser Treatment Time

  Measured in minutes and seconds. Total laser treatment time will be total cumulative lasing time.

  The duration of the procedure

Secondary Outcomes (3)

• Retreatment rate

  90 days

• Total Operative Time

  The duration of the operation

• Stone-Free Rate

  8-12 weeks after surgery

Other Outcomes (3)

• Length of stay

  0-72 hours following procedure

• Safety Profile and Adverse Events

  The duration of the operation and 90 days post procedure

• Subjective pain scores

  Immediately postoperatively through stent removal (0-14 days)

Study Arms (2)

Holmium Laser

ACTIVE COMPARATOR

Participants in this arm are randomized to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser

Device: Holmium Laser

Thulium Laser

ACTIVE COMPARATOR

Participants in this arm are randomized to be treated using the Olympus Soltive SuperPulsed Thulium Fiber Laser

Device: Thulium Laser

Interventions

Holmium Laser DEVICE

Assigned to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser.

Holmium Laser

Thulium Laser DEVICE

Assigned to be treated using the Olympus Soltive Thulium SuperPulsed Fiber Laser

Thulium Laser

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo mini PCNL for nephrolithiasis
• Stone burden (multiple stones acceptable) with largest stone 1cm - 3 cm in greatest dimension on bone window of noncontrast CT within a 6 month preoperative period.
• Able to give informed consent
• Age 21 or older

You may not qualify if:

• Patients scheduled to undergo concurrent non-PCNL procedure such as contralateral ureteroscopy
• Inability to give informed consent
• Age less than 21
• Body Mass Index (BMI) \>45
• Pregnant or breastfeeding patients
• Untreated urinary tract infections
• Uncontrolled bleeding disorder and coagulopathy
• Abnormal upper tract anatomy such as presence of ureteral strictures or complete ureteropelvic junction (UPJ) obstruction
• Patients with urinary diversion such as ileal conduit or neobladder
• Any preexisting medical condition or situation that, in the investigator's opinion, could put the participant at significant risk, confound the study results, or interfere significantly with the participants' participation in the study
• Are currently prescribed buprenorphine or methadone, or carry active diagnosis of chronic opioid use disorder

Sponsors & Collaborators

• MaineHealth: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Related Publications (21)

• Sadiq AS, Atallah W, Khusid J, Gupta M. The Surgical Technique of Mini Percutaneous Nephrolithotomy. J Endourol. 2021 Sep;35(S2):S68-S74. doi: 10.1089/end.2020.1080.

  PMID: 34499550 BACKGROUND

• Petzold R, Miernik A, Suarez-Ibarrola R. In Vitro Dusting Performance of a New Solid State Thulium Laser Compared to Holmium Laser Lithotripsy. J Endourol. 2021 Feb;35(2):221-225. doi: 10.1089/end.2020.0525. Epub 2020 Sep 9.

  PMID: 32799650 BACKGROUND

• Jiang P, Okhunov Z, Afyouni AS, Ali S, Hosseini Sharifi SH, Bhatt R, Brevik A, Ayad M, Larson K, Osann K, Patel RM, Landman J, Clayman RV. Comparison of Superpulse Thulium Fiber Laser vs Holmium Laser for Ablation of Renal Calculi in an In Vivo Porcine Model. J Endourol. 2023 Mar;37(3):335-340. doi: 10.1089/end.2022.0445.

  PMID: 36401505 BACKGROUND

• Martov AG, Ergakov DV, Guseynov M, Andronov AS, Plekhanova OA. Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. J Endourol. 2021 Jun;35(6):795-800. doi: 10.1089/end.2020.0581. Epub 2021 Jan 13.

  PMID: 33238763 BACKGROUND

• Soto-Palou F, Chen J, Medairos R, Zhong P, Antonelli J, Preminger GM, Lipkin ME. In Pursuit of the Optimal Dusting Settings with the Thulium Fiber Laser: An In Vitro Assessment. J Endourol. 2023 Aug;37(8):914-920. doi: 10.1089/end.2023.0168. Epub 2023 Jun 26.

  PMID: 37300481 BACKGROUND

• Matlaga BR, Chew B, Eisner B, Humphreys M, Knudsen B, Krambeck A, Lange D, Lipkin M, Miller NL, Monga M, Pais V, Sur RL, Shah O. Ureteroscopic Laser Lithotripsy: A Review of Dusting vs Fragmentation with Extraction. J Endourol. 2018 Jan;32(1):1-6. doi: 10.1089/end.2017.0641. Epub 2017 Nov 27.

  PMID: 29061070 BACKGROUND

• Kronenberg P, Traxer O. The laser of the future: reality and expectations about the new thulium fiber laser-a systematic review. Transl Androl Urol. 2019 Sep;8(Suppl 4):S398-S417. doi: 10.21037/tau.2019.08.01.

  PMID: 31656746 BACKGROUND

• Darr C, Krafft U, Panic A, Tschirdewahn S, Hadaschik BA, Rehme C. Renal duplication with ureter duplex not following Meyer-Weigert-Rule with development of a megaureter of the lower ureteral segment due to distal stenosis - A case report. Urol Case Rep. 2019 Nov 14;28:101038. doi: 10.1016/j.eucr.2019.101038. eCollection 2020 Jan.

  PMID: 31763165 BACKGROUND

• Nikoufar P, Hodhod A, Fathy M, Zakaria AS, Shabana W, Abdul Hadi R, Abdelkawi IF, Alaradi H, Abbas L, Alaref A, Shahrour W, Elmansy H. Thulium Fiber Laser vs Pulse-Modulated Holmium MOSES Laser in Flexible Ureteroscopy for the Management of Kidney Stones: A Single-Center Retrospective Analysis. J Endourol. 2023 Oct;37(10):1081-1087. doi: 10.1089/end.2023.0284. Epub 2023 Sep 20.

  PMID: 37597211 BACKGROUND

• Ibrahim A, Elhilali MM, Fahmy N, Carrier S, Andonian S. Double-Blinded Prospective Randomized Clinical Trial Comparing Regular and Moses Modes of Holmium Laser Lithotripsy. J Endourol. 2020 May;34(5):624-628. doi: 10.1089/end.2019.0695. Epub 2020 Apr 3.

  PMID: 32143552 BACKGROUND

• Okhunov Z, Jiang P, Afyouni AS, Ayad M, Arada R, Brevik A, Akopian G, Patel RM, Landman J, Clayman RV. Caveat Emptor: The Heat Is "ON"-An In Vivo Evaluation of the Thulium Fiber Laser and Temperature Changes in the Porcine Kidney During Dusting and Fragmentation Modes. J Endourol. 2021 Nov;35(11):1716-1722. doi: 10.1089/end.2021.0206. Epub 2021 Oct 18.

  PMID: 33906433 BACKGROUND

• Jiang P, Peta A, Brevik A, Arada RB, Ayad M, Afyouni AS, Limfueco L, Nguyen N, Palma A, Patel RM, Landman J, Clayman RV. Ex Vivo Renal Stone Dusting: Impact of Laser Modality, Ureteral Access Sheath, and Suction on Total Stone Clearance. J Endourol. 2022 Apr;36(4):499-507. doi: 10.1089/end.2021.0544.

  PMID: 34693735 BACKGROUND

• Sierra A, Corrales M, Kolvatzis M, Panthier F, Pinero A, Traxer O. Thermal Injury and Laser Efficiency with Holmium YAG and Thulium Fiber Laser-An In Vitro Study. J Endourol. 2022 Dec;36(12):1599-1606. doi: 10.1089/end.2022.0216.

  PMID: 35793107 BACKGROUND

• Petzold R, Suarez-Ibarrola R, Miernik A. Temperature Assessment of a Novel Pulsed Thulium Solid-State Laser Compared with a Holmium:Yttrium-Aluminum-Garnet Laser. J Endourol. 2021 Jun;35(6):853-859. doi: 10.1089/end.2020.0803. Epub 2020 Dec 3.

  PMID: 33191783 BACKGROUND

• Castellani D, Fong KY, Lim EJ, Chew BH, Tailly T, Emiliani E, Teoh JY, Chai CA, Heng CT, Ong Lay Keat W, Tanidir Y, Ragoori D, Galosi AB, Singh A, Bin Hamri S, Traxer O, Somani BK, Gauhar V. Comparison Between Holmium:YAG Laser with MOSES Technology vs Thulium Fiber Laser Lithotripsy in Retrograde Intrarenal Surgery for Kidney Stones in Adults: A Propensity Score-matched Analysis From the FLEXible Ureteroscopy Outcomes Registry. J Urol. 2023 Aug;210(2):323-330. doi: 10.1097/JU.0000000000003504. Epub 2023 May 1.

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• Haas CR, Knoedler MA, Li S, Gralnek DR, Best SL, Penniston KL, Nakada SY. Pulse-modulated Holmium:YAG Laser vs the Thulium Fiber Laser for Renal and Ureteral Stones: A Single-center Prospective Randomized Clinical Trial. J Urol. 2023 Feb;209(2):374-383. doi: 10.1097/JU.0000000000003050. Epub 2023 Jan 9.

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• Mahajan AD, Mahajan SA. Thulium fiber laser versus holmium:yttrium aluminum garnet laser for stone lithotripsy during mini-percutaneous nephrolithotomy: A prospective randomized trial. Indian J Urol. 2022 Jan-Mar;38(1):42-47. doi: 10.4103/iju.iju_331_21. Epub 2022 Jan 1.

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• Patil A, Reddy N, Shah D, Singh A, Ganpule A, Sabnis R, Desai M. High-Power Holmium with MOSES Technology or Thulium Fiber Laser in MiniPerc with Suction: A New Curiosity. J Endourol. 2022 Oct;36(10):1348-1354. doi: 10.1089/end.2021.0915. Epub 2022 Aug 17.

  PMID: 35331003 BACKGROUND

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  PMID: 31104731 BACKGROUND

• Higgins AM, Ganesan V, Ghani KR, Agarwal DK, Borofsky MS, Dauw CA. The 2023 Stone-Free CT Mandate: Addressing the Two Sides of the Debate. J Endourol. 2022 Dec;36(12):1522-1525. doi: 10.1089/end.2022.0610. Epub 2022 Nov 7.

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Related Links

• Holmium Laser
• Thulium Laser

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• David W Sobel, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)