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NCT Number: NCT06373419

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location status: Recruiting

Location contact

Hazem Elmansy

SUB_INVESTIGATOR

Rabail Siddiqui

CONTACT

[email protected]

(807) 684-6000

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TFL

Device

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

MOSES holmium laser

Device

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

Primary outcomes

  1. Presence of muscularis propria

    Time frame: 1 day post-procesure

    Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour

  2. Incidence of inconclusive pathology

    Time frame: 1 day post-procedure

    Incidence of inconclusive pathology due to specimen artifact

Secondary outcomes

  1. Tumor-free rate (TFR)

    Time frame: 6 to 12 weeks post-procedure

    As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy.

  2. Total operative time

    Time frame: Intraoperative

    In minutes measured from anesthesia induction until placement of the urethral catheter

  3. Total procedural time

    Time frame: Intraoperative

    In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed

  4. Number of recurrences

    Time frame: 12 weeks post-procedure

    Defined as any tumor detection by follow-up cystoscopy after the initial resection

  5. Total blood loss

    Time frame: 6 hours post-procedure

    Defined as a drop in hemoglobin level from pre-op

  6. Rate of complications

    Time frame: 4 weeks post-procedure

    Percentage of participants with post-operative complications

  7. Number of inconclusive pathology

    Time frame: 1 day post-procedure

    Number of inconclusive pathology due to thermal effect artifact.

  8. Lasing time

    Time frame: Intraoperative

    In minutes, defined as the time the laser was in use, not including pedal pauses

  9. Total energy used

    Time frame: Intraoperative

    Measured in kilojoules

  10. Frequency and severity of peri-operative complications

    Time frame: Intraoperative

    Reported according to Clavien-Dindo

Study contacts

Contact information is provided by the study sponsor or research team.

Rabail Siddiqui

CONTACT

[email protected]

(807) 684-6000

Shalyn Littlefield

CONTACT

[email protected]

(807) 684-6000

Sponsors and collaborators

Lead sponsor

Thunder Bay Regional Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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