Thulium Fiber Laser Prospective Trial (TFL)

January 30, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis

This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Flexible ureteroscopy is considered the first-line therapy for renal stones < 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
  • Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
  • Must be 18 years or older
  • Must be able to give consent
  • Bilateral ureteroscopy will be permitted but only the first side will be included in the study

Exclusion Criteria:

  • Concomitant stones in the ureter
  • Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
  • Prior radiotherapy to the abdomen or pelvis
  • Neurogenic bladder or spinal cord injury
  • Pregnancy
  • Untreated Urinary Tract Infection (UTI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lithotripsy
Ureteroscopy with lithotripsy using the Thulium Fiber Laser
Device: Thulium Fiber Laser
Thulium Fiber Laser will be used to break renal stones < 2 cm into fragments small enough to remove or pass spontaneously through the ureter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean total operative time
Time Frame: during the procedure
Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of stone retropulsion
Time Frame: during the procedure
Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy
during the procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean length of hospitalization
Time Frame: From day and time of admission to day and time of discharge
Length of hospitalization (in days) for the procedure will be recorded for each patient
From day and time of admission to day and time of discharge
Rate of postoperative complications
Time Frame: at 6 weeks
Medical chart review will be done to assess the occurence of post-operative complications
at 6 weeks
Rate of stone free status
Time Frame: at 6 weeks
Post-operative CT imaging will be reviewed to assess the occurence of ''stone free status''
at 6 weeks
Rate of need for ancillary procedures
Time Frame: at 6 weeks
Medical chart review will be done to assess the occurence of an additional ureteroscopy need to treat patients
at 6 weeks
Mean perceived workload score
Time Frame: immediately after the procedure
Effects of TFL technology on reducing surgeon perceived workload will be assessed by completing the National Aeronautics and Space Administration (NASA) Task Load Index. The tool allows to determine the subjective mental workload (MWL) of a participant while they are performing a task.The participants self-rate on a scale of 1 (low) to 20 (high). The higher the score, the worst is the outcome.
immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Mayo Clinic
University of British Columbia
University of California, San Diego
Columbia University
The Cleveland Clinic
Vanderbilt University
Ohio State University

Investigators

  • Principal Investigator: Naeem Bhojani, MD, Centre Hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-11370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Stone

Clinical Trials on Thulium Fiber Laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe