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Recruiting NCT06373419

TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors

No phase Interventional Urolithiasis of Bladder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TFL, MOSES holmium laser.
Who it may be relevant to
Registry conditions: Urolithiasis of Bladder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study

Overview

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.

Detailed description

An estimated 12,500 Canadians are diagnosed with bladder cancer each year. Diagnosis and treatment involve transurethral (through the urethra) resection of tumor or tissue called the TURBT procedure. This procedure yields excellent results and minimal morbidity and mortality but has a high recurrence rate, difficulties in the pathologic interpretation of the specimen (due to cautery effect), and procedure-related complications (excessive bleeding, bladder perforation, bowel injury, and inadvertent extensive injury to urethra) that may delay treatments such as chemotherapy which would further impact oncologic outcomes. With the advancement of technology, new methods of transurethral tumor removal have emerged, such as the use of laser energy. Using laser energy, the tumour is resected in one piece, whereas the TURBT approach requires breaking the tumor into pieces. This allows for better pathology analysis that can determine treatment pathways for the patient, as well as reduces the risk of complications. The standard lasers used have been the MOSES Holmium laser and the Thulium Fiber Laser (TFL).

Interventions

  • Device TFL
    Participant undergoing bladder tumour resection that has been randomized to this arm.
  • Device MOSES holmium laser
    Participant undergoing bladder tumour resection that has been randomized to this arm.

Primary outcome measures

  • Presence of muscularis propria [Time frame: 1 day post-procesure]
  • Incidence of inconclusive pathology [Time frame: 1 day post-procedure]
Secondary outcome measures (10)
  • Tumor-free rate (TFR) [Time frame: 6 to 12 weeks post-procedure]
  • Total operative time [Time frame: Intraoperative]
  • Total procedural time [Time frame: Intraoperative]
  • Number of recurrences [Time frame: 12 weeks post-procedure]
  • Total blood loss [Time frame: 6 hours post-procedure]
  • Rate of complications [Time frame: 4 weeks post-procedure]
  • Number of inconclusive pathology [Time frame: 1 day post-procedure]
  • Lasing time [Time frame: Intraoperative]
  • Total energy used [Time frame: Intraoperative]
  • Frequency and severity of peri-operative complications [Time frame: Intraoperative]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Thunder Bay Regional Health Sciences Centre — Thunder Bay

Identifiers

NCT: NCT06373419 · RP-1007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗