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Trial Title:
TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors
NCT ID:
NCT06373419
Condition:
Urolithiasis of Bladder
Conditions: Official terms:
Urinary Bladder Neoplasms
Urolithiasis
Urinary Bladder Calculi
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
TFL
Description:
Participant undergoing bladder tumour resection that has been randomized to this arm.
Arm group label:
Thulium Fibre Laser
Intervention type:
Device
Intervention name:
MOSES holmium laser
Description:
Participant undergoing bladder tumour resection that has been randomized to this arm.
Arm group label:
MOSES Holmonium
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.
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Thunder Bay Regional Health Sciences Centre
Address:
City:
Thunder Bay
Zip:
P7B 6V4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Rabail Siddiqui
Phone:
(807) 684-6000
Email:
rabail.siddiqui@tbh.net
Investigator:
Last name:
Hazem Elmansy
Email:
Sub-Investigator
Start date:
October 16, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Thunder Bay Regional Health Research Institute
Agency class:
Other
Source:
Thunder Bay Regional Health Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06373419
