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.
≥ 18 years of age at study entry.
Histologically confirmed intermediate-risk or high-risk NMIBC, as defined by the 2025 version of the European Association of Urology (EAU) guidelines.
ECOG Performance Status of 0-2.
Candidate for HIVEC according to clinical judgment and the device and medicinal product labeling/contra-indications.
A small bladder capacity (<150 ml), based on site standard assessment and investigator judgment.
Active or uncontrolled Urinary Tract Infection (UTI), defined as clinical signs/symptoms and/or microbiological evidence requiring treatment per investigator judgment.
Positive urine culture prior to the instillation that indicates active infection not adequately treated or controlled.
Inability to hold urine for more than 1 hour.
Single group
Hyperthermic intravesical chemotherapy (HIVEC)
DeviceHyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) using the Eight Medical Hyperthermia System IV 1.0
To assess the safety profile of the Eight Medical Hyperthermia System IV 1.0, used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in patients diagnosed with NMIBC.
Safety will be assessed by documenting all peri- and post-treatment (serious) adverse events, from the treatment onwards up to 30 days post-treatment (defined as the date of last intravesical instillation). This will include assessment of the frequency, severity, and nature of the (serious) adverse events and the treatment received.
To evaluate the performance of the Eight Medical Hyperthermia System IV 1.0, used to deliver recirculating HIVEC with MMC in patients diagnosed with NMIBC.
Device performance will be assessed during each instillation by determining: Temperature range of 40-44 °C, as measured by the catheter tip's integrated temperature sensor.
To evaluate the performance of the Eight Medical Hyperthermia System IV 1.0, used to deliver recirculating HIVEC with MMC in patients diagnosed with NMIBC.
Device performance will be assessed during each instillation by determining: Regulated temperature within ± 0.5 °C of the programmed value, at a flowrate of 200 ml/min.
To evaluate the performance of the Eight Medical Hyperthermia System IV 1.0, used to deliver recirculating HIVEC with MMC in patients diagnosed with NMIBC.
Device performance will be assessed during each instillation by determining: Adverse events as a result of device malfunction in patients, users, or other persons.
To evaluate the performance of the Eight Medical Hyperthermia System IV 1.0, used to deliver recirculating HIVEC with MMC in patients diagnosed with NMIBC.
Device performance will be assessed during each instillation by determining: Device deficiencies, which may include, but are not limited to: Inaccurate or false-negative measurements (missed alerts or shutdowns) when an intervention would have been required. False-positive measurements (unnecessary alerts or shutdowns) leading to unnecessary interventions.
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