Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2021-10-22
2022-11-28
Brief Summary
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Detailed Description
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After induction of anesthesia but before any surgical intervention, the surgeon will empty the bladder and collect a sample of urine that will serve as the "Preoperative Urine Sample". One hour following the end of the procedure, a second sample of urine will be collected from the Foley catheter that will serve as the "Immediate Post-Op Urine Sample". A third and final urine sample of urine will be collected approximately 10 days postoperatively just prior to stent removal and serve as the "Follow-up urine sample". Patients for whom all three urine specimens are collected will be considered to have completed the study. Immediately after collection, the samples will be stored in a freezer at -80 ºC. All samples will be analyzed for biomarkers of renal parenchymal injury to determine differences between pre- and postoperative concentrations. The biomarkers that will be quantified include Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and Beta-2-microglobulin (B2M).
Concentrations of urinary biomarkers are determined in duplicate from urine samples using the multiplex cytokine panel \[MILLIPLEX MAP Human Kidney Injury Panel 1 (KIM-1), Panel 2 (N-GAL2) and Panel 3 (B2 microglobulin)- Millipore Corp., Burlington, MA\] as per manufacturer's instructions. The urine samples were 1:2 diluted for Panel 1, 1:100 diluted for Panel 2 and 1:500 diluted for Panel 3. The kit provided lyophilized pre-mixed standard was reconstituted and used to generate 6-point serial dilutions and run on assay plate along with the samples. Analyte median fluorescent intensity (MFI) values were obtained.
Anticipate enrollment is 108 patients total (54 in each cohort) to adequately power the study based upon an alpha of 0.05 statistical power of 0.80.
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
* Patients undergoing unilateral ureteroscopic laser lithotripsy for the treatment of non-obstructing renal stones
* Total stone burden between 5 and 20 mm
Exclusion Criteria
* Presence of hydronephrosis preoperatively (on either side)
* CKD as defined by eGFR \< 60 mL/min
* GU anatomical anomalies (including urinary diversion, solitary kidney, ureteral stricture disease, ureteropelvic junction obstruction)
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
Principal Investigators
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Mantu Gupta
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, 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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GCO# 21-0054
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY-21-00084
Identifier Type: -
Identifier Source: org_study_id