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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium Fibre Laser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stone Free Status | Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy | 6-12 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperatively (Day 1) |
| Lasing Activity |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mantu Gupta, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39918120 | Derived | 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. |
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No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thulium Fibre Laser (TFL) | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) Thulium Fibre Laser: 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. |
| FG001 | Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser Holmium:Yttrium-Aluminum-Garnet: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thulium Fibre Laser (TFL) | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) Thulium Fibre Laser: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Stone Free Status | Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy | Posted | Count of Participants | Participants | 6-12 weeks postoperative |
|
up to 12 weeks postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thulium Fibre Laser (TFL) | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) Thulium Fibre Laser: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mantu Gupta | Icahn School of Medicine at Mount Sinai | 212-241-1272 | mantu.gupta@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2024 | Jan 6, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2023 | Jan 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Holmium:Yttrium-Aluminum-Garnet | Device | 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. |
|
|
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.
| 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. | Intraoperatively (Day 1) |
| BG001 |
| Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) |
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser Holmium:Yttrium-Aluminum-Garnet: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | mm3/sec | Intraoperatively (Day 1) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | percent of time using laser | Intraoperatively (Day 1) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | J/mm3 | Intraoperatively (Day 1) |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser Holmium:Yttrium-Aluminum-Garnet: 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |