Heated Saline for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this prospective pilot study is to evaluate the safety and feasibility of using heated saline during bladder tumor surgery in patients with non-muscle invasive bladder cancer.
The main questions it aims to answer are:
Can heated saline be given during bladder tumor removal surgery safely?
Does using heated saline keep the bladder tumor from coming back?
Researchers will compare the heated saline to room temperature saline to see if the heated saline works to prevent the bladder tumor from coming back.
Participants will:
* Have heated saline or room temperature saline during bladder tumor surgery
* Visit the clinic at 2 weeks, 3 and 6 months after bladder tumor surgery
* Complete questionnaires about quality of their life and symptoms before and after surgery
* Provide urine samples to test your urine at each visit before and after surgery
* To have a cystoscopy to check your bladder for tumors
Who Is on the Research Team?
Michael G Stencel, DO
Principal Investigator
CAMC Health System
Are You a Good Fit for This Trial?
This trial is for people with non-muscle invasive bladder cancer who are scheduled to have surgery to remove their bladder tumor. Participants must be able to attend follow-up visits and complete questionnaires.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- HISA
Trial Overview
The study is testing if using heated saline during bladder tumor removal surgery is safe and helps prevent the cancer from coming back, compared to regular room temperature saline. Patients are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT.
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CAMC Health System
Lead Sponsor
West Virginia Clinical and Translational Science Institute
Collaborator
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