CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Thulium Fibre Laser +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05350423
NCT05350423N/ACompleted

Use of Urinary Biomarkers to Quantify Degree of Renal, Parenchymal and Urothelial Damage During Ureteroscopy

Icahn School of Medicine at Mount Sinai·interventional·Posted Apr 28, 2022·Updated Dec 7, 2023

In Brief

A clinical study evaluating Thulium Fibre Laser and Holmium:Yttrium-Aluminum-Garnet for Nephrolithiasis. Completed, enrolled 108 participants across 1 site.

Detailed Summary

This is an ongoing randomized controlled trial of patients undergoing URSLL with unilateral non-obstructing renal stones. Patients are randomized to undergo URSLL with either the TFL or Ho:YAG laser. Each patient's urine is collected immediately pre-op (V1), 1 hour post-op (V2), and 10 days post-op (POD#10, V3). Samples are analyzed by enzyme-linked immunosorbent assay (ELISA) for the following biomarkers: Kidney injury molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and β2-microglobulin (β2M), then normalized to urine creatinine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNephrolithiasis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 28, 2022
Enrollment StartOct 22, 2021
Primary CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.2 years ago

Interventions

Thulium Fibre Laserdevice

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

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.