Study Results
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View full resultsBasic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2022-01-07
2024-02-01
Brief Summary
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1. A superpulsed thulium fiber laser (thulium)
2. A pulse modulated high power holmium laser (Holmium)
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Detailed Description
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1. A superpulsed thulium fiber laser (thulium)
2. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Preoperative CT scan for baseline measurements
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Mantu Gupta
Professor of Urology
Principal Investigators
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Mantu Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai West
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY-22-01521
Identifier Type: -
Identifier Source: org_study_id
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