NCT05814133

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

March 9, 2023

Last Update Submit

January 30, 2024

Conditions

Kidney Stone

Keywords

ureteroscopylithotripsythulium fiber laser

Outcome Measures

Primary Outcomes (1)

  • Mean total operative time

    Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.

    during the procedure

Secondary Outcomes (1)

  • Rate of stone retropulsion

    during the procedure

Other Outcomes (5)

  • Mean length of hospitalization

    From day and time of admission to day and time of discharge

  • Rate of postoperative complications

    at 6 weeks

  • Rate of stone free status

    at 6 weeks

  • +2 more other outcomes

Study Arms (1)

Lithotripsy

EXPERIMENTAL

Ureteroscopy with lithotripsy using the Thulium Fiber Laser

Device: Thulium Fiber Laser

Interventions

Thulium Fiber LaserDEVICE

Thulium Fiber Laser will be used to break renal stones \< 2 cm into fragments small enough to remove or pass spontaneously through the ureter.

Lithotripsy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Related Publications (6)

  • Kronenberg P, Traxer O. Update on lasers in urology 2014: current assessment on holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripter settings and laser fibers. World J Urol. 2015 Apr;33(4):463-9. doi: 10.1007/s00345-014-1395-1. Epub 2014 Sep 4.

    PMID: 25185524BACKGROUND

  • Nazif OA, Teichman JM, Glickman RD, Welch AJ. Review of laser fibers: a practical guide for urologists. J Endourol. 2004 Nov;18(9):818-29. doi: 10.1089/end.2004.18.818.

    PMID: 15659912BACKGROUND

  • Khusid JA, Khargi R, Seiden B, Sadiq AS, Atallah WM, Gupta M. Thulium fiber laser utilization in urological surgery: A narrative review. Investig Clin Urol. 2021 Mar;62(2):136-147. doi: 10.4111/icu.20200467.

    PMID: 33660440BACKGROUND

  • Kronenberg P, Hameed BZ, Somani B. Outcomes of thulium fibre laser for treatment of urinary tract stones: results of a systematic review. Curr Opin Urol. 2021 Mar 1;31(2):80-86. doi: 10.1097/MOU.0000000000000853.

    PMID: 33470684BACKGROUND

  • Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.

    PMID: 34362169BACKGROUND

  • Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.

    PMID: 30614878BACKGROUND

Related Links

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Naeem Bhojani, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naeem Bhojani, M.D

CONTACT

5148908000naeem.bhojani@gmail.com

Kahina Bensaadi, DESS

CONTACT

5148908000kahina.bensaadi.chum@ssss.gouv.qc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

April 14, 2023

Study Start

January 15, 2024

Primary Completion

January 15, 2025

Study Completion

July 15, 2025

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

CA(1)