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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Eight Medical International BVUpdated: Aug 14, 2026Locations: 2
Eligibility criteria

≥ 18 years of age at study entry. [+5]

A small bladder capacity (<150 ml), based on site standard assessment and invest... [+20]