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Feasibility of HISA During TURBT for NMIBC
Sponsor: CAMC Health System
Summary
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
Official title: A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-08-15
Completion Date
2030-05-31
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
HISA
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. Bladder irrigation with 1g of gemcitabine will be delivered in the immediate postoperative setting. The Thermaclear FluidSmart Fluid management system (Stryker, MI) will be used to administer and irrigate the bladder with normothermic or hyperthermic intravesical saline during the TURBT.
Locations (1)
Charleston Area Medical Center Memorial Hospital
Charleston, West Virginia, United States