NephrolithiasisNCT05808257
Thulium vs. Hol:YAG Laser
A study testing Thulium Fibre Laser and Holmium:Yttrium-Aluminum-Garnet in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease: 1. A superpulsed thulium fiber laser (thulium) 2. A pulse modulated high power holmium laser (Holmium) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Thulium Fibre Laser and Holmium:Yttrium-Aluminum-Garnet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing single stage unilateral RIRS for total stone burden volume >5mm to < 20 mm
- Preoperative CT scan for baseline measurements
Who cannot join
- Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
- Ureteral stent
- Uric acid component >50% on stone analysis
- Prior ureteroscopy within 6 weeks of current surgery
- Irreversible coagulopathy
- Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery
This is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
Read the detailed description
This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between >5mm to < 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers.
All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care.
The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.
- Conditions
- Nephrolithiasis
- Being tested
- Thulium Fibre Laser, Holmium:Yttrium-Aluminum-Garnet
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Fibre LaserDevice
Also called TFL
The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
Holmium:Yttrium-Aluminum-GarnetDevice
Also called Ho:YAG
The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) Receives: Device: Thulium Fibre Laser |
| Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) | Experimental | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser Receives: Device: Holmium:Yttrium-Aluminum-Garnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stone Free Status
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
Measured: 6-12 weeks postoperative
Secondary outcomes (3)
Fragmentation Speed
Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones.
Measured: Intraoperatively (Day 1)
Lasing Activity
Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones.
Measured: Intraoperatively (Day 1)
Energy Utilization
Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone.
Measured: Intraoperatively (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start7 Jan 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mantu Gupta, Icahn School of Medicine at Mount Sinai
- Investigators
- Mantu Gupta, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808257
- Sponsor's protocol ID
- STUDY-22-01521
- Status last verified
- Jan 2025
- First submitted
- 29 Mar 2023
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.
Publications
Gupta K, Ricapito A, Connors C, Khargi R, Yaghoubian AJ, Gallante B, Atallah WM, Gupta M. Is There a Winner? Prospective Randomized Controlled Trial Comparing SuperPulse Thulium Fiber Laser vs Pulse-Modulated High-Power Holmium:YAG Laser for Retrograde Intrarenal Surgery. J Urol. 2025 Mar;213(3):274-282. doi: 10.1097/JU.0000000000004310. Epub 2025 Feb 7.
PubMed 39918120
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT05808257
- Acronym / sponsor ID
- STUDY-22-01521
- Conditions
- Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Posted 29 Jan 2025
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 randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
Detailed description
This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between >5mm to < 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers.
All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care.
The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Device: Thulium Fibre LaserPatients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) |
| Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) | Experimental | Device: Holmium:Yttrium-Aluminum-GarnetPatients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing single stage unilateral RIRS for total stone burden volume >5mm to < 20 mm
- Preoperative CT scan for baseline measurements
Key exclusion criteria (6 listed)
- Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
- Ureteral stent
- Uric acid component >50% on stone analysis
- Prior ureteroscopy within 6 weeks of current surgery
- Irreversible coagulopathy
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 |
|---|---|---|
| Thulium Fibre LaserAlso: TFLThe TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation. | Device | Thulium Fibre Laser (TFL) |
| Holmium:Yttrium-Aluminum-GarnetAlso: Ho:YAGThe Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy. | Device | Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) |
Primary outcome
Number of Participants With Stone Free Status
Time frame: 6-12 weeks postoperative
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
3 secondary outcomes
Fragmentation Speed
Time frame: Intraoperatively (Day 1)
Lasing Activity
Time frame: Intraoperatively (Day 1)
Energy Utilization
Time frame: Intraoperatively (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39918120Gupta K, Ricapito A, Connors C, Khargi R, Yaghoubian AJ, Gallante B, Atallah WM, Gupta M. Is There a Winner? Prospective Randomized Controlled Trial Comparing SuperPulse Thulium Fiber Laser vs Pulse-Modulated High-Power Holmium:YAG Laser for Retrograde Intrarenal Surgery. J Urol. 2025 Mar;213(3):274-282. doi: 10.1097/JU.0000000000004310. Epub 2025 Feb 7.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.
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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. This study is not recruiting at the moment.
Mantu Gupta, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium Fibre Laser and Holmium:Yttrium-Aluminum-Garnet in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Stone Free Status (time frame: 6-12 weeks postoperative). 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 NCT05808257, which also lists 1 linked publication.
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 29 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.