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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis of Bladder
• Intervention / Treatment: Device: TFL; Device: MOSES holmium laser

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabail Siddiqui; Phone Number: (807) 684-6000; Email: rabail.siddiqui@tbh.net
• Study Contact Backup: Name: Shalyn Littlefield; Phone Number: (807) 684-6000; Email: shalyn.littlefield@tbh.net

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Recruiting
      • Thunder Bay Regional Health Sciences Centre
      • Contact: Rabail Siddiqui; Phone Number: (807) 684-6000; Email: rabail.siddiqui@tbh.net
      • Sub-Investigator: Hazem Elmansy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thulium Fibre Laser; Participants randomized to this arm will undergo bladder resection using the TFL laser	Device: TFL; Participant undergoing bladder tumour resection that has been randomized to this arm.
Active Comparator: MOSES Holmonium; Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser.	Device: MOSES holmium laser; Participant undergoing bladder tumour resection that has been randomized to this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of muscularis propria	Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour	1 day post-procesure
Incidence of inconclusive pathology	Incidence of inconclusive pathology due to specimen artifact	1 day post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor-free rate (TFR)	As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy.	6 to 12 weeks post-procedure
Total operative time	In minutes measured from anesthesia induction until placement of the urethral catheter	Intraoperative
Total procedural time	In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed	Intraoperative
Number of recurrences	Defined as any tumor detection by follow-up cystoscopy after the initial resection	12 weeks post-procedure
Total blood loss	Defined as a drop in hemoglobin level from pre-op	6 hours post-procedure
Rate of complications	Percentage of participants with post-operative complications	4 weeks post-procedure
Number of inconclusive pathology	Number of inconclusive pathology due to thermal effect artifact.	1 day post-procedure
Lasing time	In minutes, defined as the time the laser was in use, not including pedal pauses	Intraoperative
Total energy used	Measured in kilojoules	Intraoperative
Frequency and severity of peri-operative complications	Reported according to Clavien-Dindo	Intraoperative

Collaborators and Investigators

• Sponsor: Thunder Bay Regional Health Research Institute
• Investigators: Principal Investigator: Ahmed Z Ahmed, Thunder Bay Regional Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Urolithiasis; Urinary Bladder Calculi
• Other Study ID Numbers: RP-1007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No