Recruiting

TFL vs. Holmium

Sponsor:

Thunder Bay Regional Health Research Institute

Code:

NCT05598645

Conditions

Kidney Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thulium Fibre Laser

MOSES Holmium Laser

Study Details

Brief summary:

This study aims to compare the efficacy and safety of both types of lasers, Holmium MOSES and TFL, in management of kidney stones requiring treatment.

Conditions

Kidney Stone

Study ID

NCT05598645

Start date

Aug 16, 2022

Status verified date

Aug, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years of age and over at the time of enrollment.
2. Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
3. Written informed consent to participate in the study
4. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

1. Patients with ipsilateral distal ureteral stones or stricture.
2. Stone size > 20 mm or multiple kidney stones in different calyces.
3. Previous shock wave lithotripsy (SWL) treatment for the same stone.
4. Participants with active urinary tract infection until appropriately treated
5. Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
6. Pregnancy.
7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
8. Participants who are uncooperative or cannot follow instructions.
9. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.
10. Patients with solitary kidney.

Study Design

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Thulium Fibre Laser (TFL)

Patients randomized to this arm will undergo treatment using the TFL.

experimental: MOSES Holmium Laser

Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.

Interventions

Thulium Fibre Laser

Participants will undergo treatment using the TFL

MOSES Holmium Laser

Participants will undergo treatment using the MOSES Holmium laser.

Primary outcome measure

  • Procedural Time [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Locations

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Contacts

Shalyn Littlefield, MSc

shalyn.littlefield@tbh.net

More Information

Sponsor

Thunder Bay Regional Health Research Institute

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thunder Bay Regional Health Research Institute on 2024-08-07.