Clinical Trial

Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.

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Summary
The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in adult patients with non-muscle invasive bladder cancer (NMIBC). The main questions it aims to answer are: * Is the Eight Medical Hyperthermia System IV 1.0 safe when used to deliver HIVEC with MMC in adult patients with NMIBC? * Does the Eight Medical Hyperthermia System IV 1.0 perform as intended by successfully delivering HIVEC with MMC? Participants will: * Receive HIVEC treatment with MMC using the Eight Medical Hyperthermia System IV 1.0 according to the study treatment schedule. * Attend scheduled study visits for safety assessments, clinical evaluations, and follow-up.
Trial Details
NCT Number NCT07758881
Lead Sponsor Eight Medical International BV
Conditions Non-muscle Invasive Bladder Cancer (NMIBC)
Enrollment 30 participants
Start Date 2027-01
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-14