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

Korábbi kezelés

• Positive urine culture prior to the instillation that indicates active infection not adequately treated or controlled.
• Gross hematuria that precludes safe catheterization or intravesical therapy.
• Known vesico-ureteral reflux that increases risk with intravesical chemotherapy.
• Prior HIVEC or intravesical chemotherapy is permitted, provided a minimum washout period of 6 months has elapsed since the last instillation and there are no ongoing clinically significant adverse events from prior treatments.
• Participants with concurrent chemotherapy.
• Participant is enrolled in another study or there is concurrent participation or participation within 30 days in any other clinical trial with an investigational product.

Más betegség

• Active or uncontrolled Urinary Tract Infection (UTI), defined as clinical signs/symptoms and/or microbiological evidence requiring treatment per investigator judgment.
• Urethral strictures or other anatomical/functional conditions that complicate or prevent safe catheterization.
• Known allergy or hypersensitivity to Mitomycin C.
• Current or history of clinically significant hematologic disorder that may increase risk of bleeding, infection, or systemic toxicity, or confound safety assessment.
• Autoimmune disease, systemic inflammatory disease or other medical conditions that will likely affect study outcomes or participant safety.
• Tumor tissue in the bladder containing <50% urothelial cancer.
• (A history of) muscle-invasive bladder cancer (≥ T2) or metastatic disease.
• Participants with a history of other active malignancies are excluded, except in cases where the malignancy is considered adequately treated, clinically stable, and unlikely to interfere with the safety or efficacy evaluation of the investigational treatment.

Egyéb

• A small bladder capacity (<150 ml), based on site standard assessment and investigator judgment.
• Inability to hold urine for more than 1 hour.
• Severe bladder wall damage or other bladder pathology that increases the risk of complications or prevents safe instillation.
• Non-controlled bladder overactivity that prevents completion of the planned dwell time.
• Inability to remain in the supine position for at least 60 minutes.
• Participant is pregnant, plans to become pregnant, or is lactating.
• Male participants who are not vasectomized, and are unwilling or unable to use a highly effective method of contraception.

• ≥ 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.
• The participant and investigator signed and dated the informed consent form prior to the treatment.
• Available, willing, and with sufficient cognitive awareness to comply with the protocol or proposed follow-up visits.