NephrolithiasisHOTLaserNCT06266793
Comparison of Holmium Laser and Thulium Laser for Mini PCNL
A study testing Holmium Laser and Thulium Laser in people with Nephrolithiasis and Percutaneous Nephrolithotomy, run by MaineHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Nephrolithiasis, Percutaneous Nephrolithotomy
- What is being tested?
- Holmium Laser and Thulium Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Stone burden outside of inclusion criteria range
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Lumenis Pulse 120H Moses 2.0 Holmium Laser vs. Olympus Soltive Thulium Fiber Laser for Mini-percutaneous Nephrolithotomy
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.
Read the detailed description
Multiple procedural modalities for treating nephrolithiasis are available to patients with the ultimate choice dependent on stone size, location, and patient factors. For over 30 years, the holmium: yttrium-aluminum-garnet (Ho:YAG) laser has been the gold standard for laser lithotripsy due to its efficiency in stone fragmentation irrespective of stone composition and its enviable safety profile. Different energies, pulse rates, pulse durations, and work settings are utilized based on stone density and surgeon intent for fragmentation versus dusting.
Basic physical principles underlie the effectiveness of the Ho:YAG laser, which made a revolution over two decades ago. Energy is transmitted through a flexible quartz fiber that varies in size from 150-1,000 micrometers making it amenable to flexible ureteroscopy. Its wavelength of 2,100 nm is effectively absorbed by water conferring a safety profile which is further bolstered by its 0.4mm depth of penetration. The photothermal mechanism by which it exerts force requires direct stone contact leading to stone vaporization. As a pulsed laser, holmium emits a cyclic burst of light wavelength with a corresponding omission. The average of the laser's pulses accounts for the power output. Contemporary advancements have led to utilization of higher power by taking advantage of the pulse technology. At present pulse duration can be lengthened from 350 microseconds to 1500 microseconds and utilized to reduce stone retropulsion. The latest evolution of the technology includes the aptly named "Moses Technology" (now in version 2.0) whereby a short vapor bubble precedes a longer duration, high energy pulse that can conserve energy by means of travel through the vapor bubble. This technology has been key in reducing stone retropulsion leading to improved ablation rates. Data has suggested that the Moses technology improves patient outcomes by reducing procedural duration and reducing fragmentation time.
A newer alternative to the Ho:YAG laser is the thulium fiber laser (TFL) lithotripter, introduced in 2018. It can provide greater power output from a smaller fiber core due to the diode construction with silica chemically doped with thulium ions. This is achieved by using a 50-150 micrometer optical laser fiber core rather than mirrors to focus light energy as in the Ho:YAG. Small form factor renders the fiber more adaptable in acute angle applications. The low power consumption of the TFL arises from fan cooling and plug efficiency permitting increased pulse repetition rates up to 2,000 - 2,200 Hz with pulse durations from 0.2 to 12 milliseconds. Due to these improvements, the TFL can both fragment and dust with moderated heat generation. Moreover, the TFL is compatible with variable operating room configurations based on its standard electrical wall socket (110V) making it more accessible. Similar to the Ho:YAG laser its wavelength varies between 1,908 and 1,940 nm bestowing a higher absorption coefficient in water which grants a similar safety profile owing to higher energy density focused at the tip of the laser fiber. In summation, the TFL has comparable results for stone ablation and low retropulsion with lower power consumption and less retropulsion leading to better dusting.
Recent studies have compared specific features of each laser to standardize best practices albeit with no clear winner. Pulse profiles differ with each laser. The Ho:YAG pulse has an acute spike in voltage with a dramatic drop within 150 microseconds whereas the TFL pulse profile has an acute upsurge that is sustained for the duration of the pulse. This inherent property within the TFL allows greater dialed in variability. With regard to energy absorption the TFL has been shown to be 4-5 times more effective thus correlating with lower pulsed energies for stone ablation in the in vitro setting. Lower pulsed energies in conjunction with increased pulse durations allow for less retropulsion with better dusting. The TFL has demonstrable improvements in stone free rates by more readily creating fine dust than can the Ho:YAG and the Ho:YAG-MOSES in in vivo settings. Not to be undone, the Ho:YAG laser has statistically higher ablation rates at slow speeds of 500 mm/min when using approximately identical energies and frequencies. Data suggests that higher ablation rates are more readily obtained at high-powered settings (24W) albeit with increased risk for thermal damage. Moreover, in vivo models suggest increased risk for urothelial tissue injury when using TFL in the absence or ureteral access sheaths owing to increased temperature within the collecting system. At best, current in vivo and in vitro studies lack certain corollary to clinical scenarios however they do suggest an equivalency for tissue temperature damage by either laser modality via high-power low-irrigation settings. When going head-to-head the Ho:YAG has shown superiority with denser calcium phosphate stones. TFL may confer greater stone clearance but has also been found to increase the rate of infectious complications. Other studies have concluded no significant clinical time advantage, stone free rate, complication, or patient related stone quality of life outcomes. Therefore as both lasers confer safety with effectiveness, surgeon preference and institutional preference may dictate technological approach.
Studies have begun to compare TFL to high power holmium with Moses technology for ureteroscopy and laser lithotripsy (URSLL), however, data is lacking as to the superior laser technology for medium or large stones approached antegrade in the mini percutaneous nephrolithotomy (PCNL) setting.
This is a single institution, single surgeon, randomized controlled trial that evaluates the holmium laser vs. the thulium laser for medium-to-large stones in the mini Percutaneous Nephrolithotomy setting. Patients will be screened and consented for participation in this study, and will be randomized to be treated using either the holmium or thulium laser for their procedure. This study aims to evaluate the efficiency of both FDA-approved lasers for this procedure to ascertain whether one of them has any advantage over the other. Procedural information will be evaluated as well as up to 90 day outcomes for the participants of this trial.
- Conditions
- Nephrolithiasis, Percutaneous Nephrolithotomy
- Being tested
- Holmium Laser, Thulium Laser
- Keywords
- Laser, Holmium laser, Thulium fiber laser, PCNL, Nephrolithiasis, Percutaneous Nephrolithotomy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium LaserDevice
Assigned to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser.
Thulium LaserDevice
Assigned to be treated using the Olympus Soltive Thulium SuperPulsed Fiber Laser
| Study group | Role | What they receive |
|---|---|---|
| Holmium Laser | Active comparator | Participants in this arm are randomized to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser Receives: Device: Holmium Laser |
| Thulium Laser | Active comparator | Participants in this arm are randomized to be treated using the Olympus Soltive SuperPulsed Thulium Fiber Laser Receives: Device: Thulium Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser Treatment Time
Measured in minutes and seconds. Total laser treatment time will be total cumulative lasing time.
Measured: The duration of the procedure
Secondary outcomes (3)
Retreatment rate
Participants undergoing ureteroscopy, shockwave lithotripsy or repeat percutaneous stone treatment for the same stone(s) within 90 days.
Measured: 90 days
Total Operative Time
The time the procedure takes, starting at time of instrument insertion after positioning and draping and end at instrument removal.
Measured: The duration of the operation
Stone-Free Rate
No fragments greater than 3 mm in greatest dimension measured on low-dose noncontrast CT imaging approximately 8-12 weeks after surgery.
Measured: 8-12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start7 Mar 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, David Sobel, MaineHealth
- Investigators
- David W Sobel, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266793
- Sponsor's protocol ID
- 2072488-2
- Acronym
- HOTLaser
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34499550Petzold 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.
PubMed 32799650Jiang 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.
PubMed 36401505Martov 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.
PubMed 33238763Soto-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.
PubMed 37300481Matlaga 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.
PubMed 29061070Kronenberg 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.
PubMed 31656746Darr 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.
PubMed 31763165Nikoufar 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.
PubMed 37597211Ibrahim 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.
PubMed 32143552Okhunov 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.
PubMed 33906433Jiang 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.
PubMed 34693735Sierra 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.
PubMed 35793107Petzold 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.
PubMed 33191783Castellani 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.
PubMed 37126223
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lumenis Pulse 120H Moses 2.0 Holmium Laser vs. Olympus Soltive Thulium Fiber Laser for Mini-percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT06266793
- Acronym / sponsor ID
- HOTLaser / 2072488-2
- Conditions
- Nephrolithiasis, Percutaneous Nephrolithotomy
- Keywords
- Laser, Holmium laser, Thulium fiber laser, PCNL, Nephrolithiasis, Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple procedural modalities for treating nephrolithiasis are available to patients with the ultimate choice dependent on stone size, location, and patient factors. For over 30 years, the holmium: yttrium-aluminum-garnet (Ho:YAG) laser has been the gold standard for laser lithotripsy due to its efficiency in stone fragmentation irrespective of stone composition and its enviable safety profile. Different energies, pulse rates, pulse durations, and work settings are utilized based on stone density and surgeon intent for fragmentation versus dusting.
Basic physical principles underlie the effectiveness of the Ho:YAG laser, which made a revolution over two decades ago. Energy is transmitted through a flexible quartz fiber that varies in size from 150-1,000 micrometers making it amenable to flexible ureteroscopy. Its wavelength of 2,100 nm is effectively absorbed by water conferring a safety profile which is further bolstered by its 0.4mm depth of penetration. The photothermal mechanism by which it exerts force requires direct stone contact leading to stone vaporization. As a pulsed laser, holmium emits a cyclic burst of light wavelength with a corresponding omission. The average of the laser's pulses accounts for the power output. Contemporary advancements have led to utilization of higher power by taking advantage of the pulse technology. At present pulse duration can be lengthened from 350 microseconds to 1500 microseconds and utilized to reduce stone retropulsion. The latest evolution of the technology includes the aptly named "Moses Technology" (now in version 2.0) whereby a short vapor bubble precedes a longer duration, high energy pulse that can conserve energy by means of travel through the vapor bubble. This technology has been key in reducing stone retropulsion leading to improved ablation rates. Data has suggested that the Moses technology improves patient outcomes by reducing procedural duration and reducing fragmentation time.
A newer alternative to the Ho:YAG laser is the thulium fiber laser (TFL) lithotripter, introduced in 2018. It can provide greater power output from a smaller fiber core due to the diode construction with silica chemically doped with thulium ions. This is achieved by using a 50-150 micrometer optical laser fiber core rather than mirrors to focus light energy as in the Ho:YAG. Small form factor renders the fiber more adaptable in acute angle applications. The low power consumption of the TFL arises from fan cooling and plug efficiency permitting increased pulse repetition rates up to 2,000 - 2,200 Hz with pulse durations from 0.2 to 12 milliseconds. Due to these improvements, the TFL can both fragment and dust with moderated heat generation. Moreover, the TFL is compatible with variable operating room configurations based on its standard electrical wall socket (110V) making it more accessible. Similar to the Ho:YAG laser its wavelength varies between 1,908 and 1,940 nm bestowing a higher absorption coefficient in water which grants a similar safety profile owing to higher energy density focused at the tip of the laser fiber. In summation, the TFL has comparable results for stone ablation and low retropulsion with lower power consumption and less retropulsion leading to better dusting.
Recent studies have compared specific features of each laser to standardize best practices albeit with no clear winner. Pulse profiles differ with each laser. The Ho:YAG pulse has an acute spike in voltage with a dramatic drop within 150 microseconds whereas the TFL pulse profile has an acute upsurge that is sustained for the duration of the pulse. This inherent property within the TFL allows greater dialed in variability. With regard to energy absorption the TFL has been shown to be 4-5 times more effective thus correlating with lower pulsed energies for stone ablation in the in vitro setting. Lower pulsed energies in conjunction with increased pulse durations allow for less retropulsion with better dusting. The TFL has demonstrable improvements in stone free rates by more readily creating fine dust than can the Ho:YAG and the Ho:YAG-MOSES in in vivo settings. Not to be undone, the Ho:YAG laser has statistically higher ablation rates at slow speeds of 500 mm/min when using approximately identical energies and frequencies. Data suggests that higher ablation rates are more readily obtained at high-powered settings (24W) albeit with increased risk for thermal damage. Moreover, in vivo models suggest increased risk for urothelial tissue injury when using TFL in the absence or ureteral access sheaths owing to increased temperature within the collecting system. At best, current in vivo and in vitro studies lack certain corollary to clinical scenarios however they do suggest an equivalency for tissue temperature damage by either laser modality via high-power low-irrigation settings. When going head-to-head the Ho:YAG has shown superiority with denser calcium phosphate stones. TFL may confer greater stone clearance but has also been found to increase the rate of infectious complications. Other studies have concluded no significant clinical time advantage, stone free rate, complication, or patient related stone quality of life outcomes. Therefore as both lasers confer safety with effectiveness, surgeon preference and institutional preference may dictate technological approach.
Studies have begun to compare TFL to high power holmium with Moses technology for ureteroscopy and laser lithotripsy (URSLL), however, data is lacking as to the superior laser technology for medium or large stones approached antegrade in the mini percutaneous nephrolithotomy (PCNL) setting.
This is a single institution, single surgeon, randomized controlled trial that evaluates the holmium laser vs. the thulium laser for medium-to-large stones in the mini Percutaneous Nephrolithotomy setting. Patients will be screened and consented for participation in this study, and will be randomized to be treated using either the holmium or thulium laser for their procedure. This study aims to evaluate the efficiency of both FDA-approved lasers for this procedure to ascertain whether one of them has any advantage over the other. Procedural information will be evaluated as well as up to 90 day outcomes for the participants of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium Laser | Active comparator | Device: Holmium LaserParticipants in this arm are randomized to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser |
| Thulium Laser | Active comparator | Device: Thulium LaserParticipants in this arm are randomized to be treated using the Olympus Soltive SuperPulsed Thulium Fiber Laser |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium LaserAssigned to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser. | Device | Holmium Laser |
| Thulium LaserAssigned to be treated using the Olympus Soltive Thulium SuperPulsed Fiber Laser | Device | Thulium Laser |
Primary outcome
Laser Treatment Time
Time frame: The duration of the procedure
Measured in minutes and seconds. Total laser treatment time will be total cumulative lasing time.
3 secondary outcomes
Retreatment rate
Time frame: 90 days
Total Operative Time
Time frame: The duration of the operation
Stone-Free Rate
Time frame: 8-12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 34499550Sadiq 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.
- Background: PubMed 32799650Petzold 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.
- Background: PubMed 36401505Jiang 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.
- Background: PubMed 33238763Martov 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.
- Background: PubMed 37300481Soto-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.
- Background: PubMed 29061070Matlaga 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.
- Background: PubMed 31656746Kronenberg 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.
- Background: PubMed 31763165Darr 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.
- Background: PubMed 37597211Nikoufar 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.
- Background: PubMed 32143552Ibrahim 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.
- Background: PubMed 33906433Okhunov 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.
- Background: PubMed 34693735Jiang 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.
- Holmium LaserLink provided by the sponsor.
- Thulium LaserLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Nephrolithiasis
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David W Sobel, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium Laser and Thulium Laser in people with Nephrolithiasis and Percutaneous Nephrolithotomy, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser Treatment Time (time frame: The duration of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266793, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.