Thermaclear heated-saline intravesical hyperthermia + gemcitabine (DNA synthesis inhibitor) in NMIBC

This prospective, randomized two-arm pilot study tests whether hyperthermic intravesical saline irrigation (42.0 ± 2°C) can be delivered safely and feasibly during TURBT for low- to intermediate-risk non–muscle-invasive bladder cancer, and whether it appears to reduce early recurrence signals. Patients undergo standard TURBT with either normothermic or heated saline irrigation delivered using Stryker’s Thermaclear FluidSmart fluid management system, and both arms receive immediate postoperative intravesical gemcitabine (a nucleoside analog chemotherapy that inhibits DNA synthesis). The sponsor is CAMC Health System; the key “product owners” here are Stryker (device platform) and generic drug manufacturers of gemcitabine (drug component), with the scientific angle being an intraoperative, device-enabled “regional biology” intervention rather than a new systemic agent. The feasibility endpoint emphasizes protocol adherence (including maintaining target temperature for most of the intended exposure) plus recruitment/retention, with recurrence tracked as an exploratory clinical outcome. Today’s care for low/intermediate-risk NMIBC is complete endoscopic resection followed by risk-adapted intravesical therapy (often a single postoperative chemo instillation such as gemcitabine or mitomycin, with cystoscopic surveillance), and this study asks whether adding controlled heat during resection can further blunt the high recurrence tendency.