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

Thunder Bay Regional Health Research Institute

Status: Enrolling

Conditions: Urolithiasis of Bladder

Treatments: Device: TFL; Device: MOSES holmium laser

Study type: Interventional

Funder types: Other

Identifiers

NCT06373419

RP-1007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Thulium Fibre Laser

Active Comparator group

Description:

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

Treatment:

Device: TFL

MOSES Holmonium

Active Comparator group

Description:

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

Treatment:

Device: MOSES holmium laser