NCT05350423

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

April 22, 2022

Results QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (3)

  • Change in Kidney Injury Molecule-1 (KIM-1)

    Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.

    Baseline, 1 hour postoperatively, and 10 days postoperatively

  • Change in Neutrophil Gelatinase-associated Lipocalin (NGAL)

    Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.

    Baseline, 1 hour postoperatively, and 10 days postoperatively

  • Change in β2-microglobulin (β2M)

    Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.

    Baseline, 1 hour postoperatively, and 10 days postoperatively

Secondary Outcomes (1)

  • Operative Time

    Day 1, Intraoperatively

Study Arms (2)

Thulium Fibre Laser (TFL)

EXPERIMENTAL

Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)

Device: Thulium Fibre Laser

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

Device: Holmium:Yttrium-Aluminum-Garnet

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.

Also known as: TFL
Thulium Fibre Laser (TFL)
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.

Also known as: Ho:YAG
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years
  • Patients undergoing unilateral ureteroscopic laser lithotripsy for the treatment of non-obstructing renal stones
  • Total stone burden between 5 and 20 mm

You may not qualify if:

  • Presence of pre-existing indwelling ureteral stent
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Results Point of Contact

Title
Dr. Mantu Gupta
Organization
Icahn School of Medicine at Mount Sinai
Mantu.Gupta@mountsinai.org
212-241-1272

Study Officials

  • Mantu Gupta

    Department of Urology, Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

October 22, 2021

Primary Completion

November 28, 2022

Study Completion

November 28, 2022

Last Updated

December 7, 2023

Results First Posted

December 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

All data will be presented/shared as aggregates.

Locations

US(1)