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The purpose of this study is to compare two laser technologies that are routinely used during ureteroscopy for the treatment of kidney stones. Specifically, this study will compare a pulsed Thulium:YAG laser to a pulse-modulated Holmium:YAG laser (Moses technology) to evaluate how effective and safe they are when used to break kidney stones.
Primary endpoints include stone-free rate and the zero stone-free rate at a standardized postoperative. Secondary endpoints include total operative time, lasing time (s), laser energy expended (J), efficiency (laser energy expended/stone volume; stone volume/lasing time). These endpoints aim to provide a comprehensive assessment of the clinical effectiveness and procedural efficiency of the two laser systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Thulium:YAG laser | Experimental | Flexible Ureterorenoscopy (URS) for kidney stone treatment will be performed per standard medical care, and surgeons will use the Pulsed Thulium:YAG laser during the procedure. |
|
| Pulse-modulated Holmium:YAG laser | Experimental | Flexible Ureterorenoscopy (URS) will be performed using standard techniques without deviation from routine care, and surgeons will use the pulse-modulated Holmium:YAG laser during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moses Holmium:YAG laser | Device | Ho:YAG with Moses pulse modulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate (absence of any fragments ≥ 2mm) | Month 1 | |
| Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month) | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | From first insertion of instruments to final removal of all instruments (up to 3 hours) | |
| Lasing time | From start of lasing to end of lasing (up to 1 hour) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esteban Emiliani, MD, PhD | Contact | 646-290-4549 | esteban.emilianisanz@nyulangone.org | |
| Rozalba Gogaj, MD, MPH | Contact | 646-825-5663 | Rozalba.gogaj@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Esteban Emiliani, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| NYU Langone Health |
The de-identified participant data from the final research dataset will be shared to achieve aims in the approved proposal beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting researcher provide a methodologically sound proposal and executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: esteban.emilianisanz@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Researchers who provide a methodologically sound proposal will be granted access to achieve aims in the approved proposal. Requests should be directed to esteban.emilianisanz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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A simple randomization scheme will be used to assign a laser to each case according to a predefined allocation scheme. Randomization will be conducted prior to surgery, and allocation will be concealed until the start of the operating room workflow.
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The case coordinator will inform the operating surgeon of the assigned laser before the procedure begins. Study participants will remain blinded to the laser assignment. Outcome assessments, including imaging based evaluation, will be performed by personnel who are blinded to treatment allocation.
| Thulium:YAG laser | Device | p-Tm:YAG laser lithotripsy with long pulse mode |
|
|
| Laser energy expended (J) |
| From start of lasing to end of lasing (up to 1 hour) |
| Laser energy expended per stone volume | From start of lasing to end of lasing (up to 1 hour) |
| Stone volume per lasing time | From start of lasing to end of lasing (up to 1 hour) |
| New York |
| New York |
| 10016 |
| United States |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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