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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2023
CompletedFirst Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedApril 18, 2024
April 1, 2024
2 years
April 15, 2024
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Tumor-free rate (TFR)
6 to 12 weeks post-procedure
Total operative time
Intraoperative
Total procedural time
Intraoperative
Number of recurrences
12 weeks post-procedure
Total blood loss
6 hours post-procedure
- +5 more secondary outcomes
Study Arms (2)
Thulium Fibre Laser
ACTIVE COMPARATORParticipants randomized to this arm will undergo bladder resection using the TFL laser
MOSES Holmonium
ACTIVE COMPARATORParticipants randomized to this arm will undergo bladder resection using the MOSES holmium laser.
Interventions
Participant undergoing bladder tumour resection that has been randomized to this arm.
Participant undergoing bladder tumour resection that has been randomized to this arm.
Eligibility Criteria
You may qualify if:
- Over 18 years of age at the time of enrollment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Z Ahmed
Thunder Bay Regional Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Urologist
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 18, 2024
Study Start
October 16, 2023
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share