Recruiting

TFL vs. MOSES

Sponsor:

Thunder Bay Regional Health Research Institute

Code:

NCT06373419

Conditions

Urolithiasis of Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TFL

MOSES holmium laser

Study Details

Brief summary:

The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.

The main question it aims to answer is:

Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?

Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.

Conditions

Urolithiasis of Bladder

Study ID

NCT06373419

Start date

Oct 16, 2023

Status verified date

Apr, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Over 18 years of age at the time of enrollment.
2. Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.

Exclusion Criteria:

1. Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
2. Synchronous either urethral tumors or upper urinary tract tumor
3. History of Carcinoma in situ
4. Contracted bladder

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Thulium Fibre Laser

Participants randomized to this arm will undergo bladder resection using the TFL laser

active comparator: MOSES Holmonium

Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser.

Interventions

TFL

Participant undergoing bladder tumour resection that has been randomized to this arm.

MOSES holmium laser

Participant undergoing bladder tumour resection that has been randomized to this arm.

Primary outcome measure

  • Presence of muscularis propria [ Time Frame: 1 day post-procesure ]
  • Incidence of inconclusive pathology [ Time Frame: 1 day post-procedure ]

Central Contacts and Locations

Central contacts

Rabail Siddiqui

(807) 684-6000rabail.siddiqui@tbh.net

Shalyn Littlefield

(807) 684-6000shalyn.littlefield@tbh.net

Locations

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Contacts

Rabail Siddiqui

(807) 684-6000rabail.siddiqui@tbh.net

More Information

Sponsor

Thunder Bay Regional Health Research Institute

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thunder Bay Regional Health Research Institute on 2024-04-18.