Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373419
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors
Sponsor:
Thunder Bay Regional Health Research Institute
Organization:
Thunder Bay Regional Health Research Institute
Study Overview
Official Title:
Thulium Fiber Laser TFL Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors A Randomized Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 12500 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None