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

N/ANot Yet RecruitingNCT07758881

Eight Medical International BV30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years of age at study entry. 2. Histologically confirmed intermediate-risk or high-risk NMIBC, as defined by the 2025 version of the European Association of Urology (EAU) guidelines. 3. ECOG Performance Status of 0-2. 4. Candidate for HIVEC according to clinical judgment and the device and medicinal product labeling/contra-indications. 5. The participant and investigator signed and dated the informed consent form prior to the treatment. 6. Available, willing, and with sufficient cognitive awareness to comply with the protocol or proposed follow-up visits. Exclusion Criteria: 1. A small bladder capacity (\<150 ml), based on site standard assessment and investigator judgment. 2. Active or uncontrolled Urinary Tract Infection (UTI), defined as clinical signs/symptoms and/or microbiological evidence requiring treatment per investigator judgment. 3. Positive urine culture prior to the instillation that indicates active infection not adequately treated or controlled. 4. Inability to hold urine for more than 1 hour. 5. Gross hematuria that precludes safe catheterization or intravesical therapy. 6. Severe bladder wall damage or other bladder pathology that increases the risk of complications or prevents safe instillation. 7. Non-controlled bladder overactivity that prevents completion of the planned dwell time. 8. Urethral strictures or other anatomical/functional conditions that complicate or prevent safe catheterization. 9. Known vesico-ureteral reflux that increases risk with intravesical chemotherapy. 10. Inability to remain in the supine position for at least 60 minutes. 11. Known allergy or hypersensitivity to Mitomycin C. 12. Current or history of clinically significant hematologic disorder that may increase risk of bleeding, infection, or systemic toxicity, or confound safety assessment. 13. Autoimmune disease, systemic inflammatory disease or other medical conditions that will likely affect study outcomes or participant safety. 14. Tumor tissue in the bladder containing \<50% urothelial cancer. 15. (A history of) muscle-invasive bladder cancer (≥ T2) or metastatic disease. 16. 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. 17. 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. 18. Participants with concurrent chemotherapy. 19. Participant is pregnant, plans to become pregnant, or is lactating. 20. Male participants who are not vasectomized, and are unwilling or unable to use a highly effective method of contraception. 21. 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.

Outcomes

Primary Outcomes

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.

Time frame: Visit 1 (week 1), visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 5), visit 6 (week 6), visit 7 (week 10), visit 8 (week 14), visit 9 (week 18), visit 10 (week 22), visit 11 (week 26), visit 12 (week 30), study exit visit (week 34)

Secondary Outcomes

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.

To evaluate the usability of the Eight Medical Hyperthermia System IV 1.0, used to deliver recirculating HIVEC with MMC in patients diagnosed with NMIBC.

Device usability will be assessed through a structured questionnaire administered to device operators, evaluating their overall satisfaction with the Eight Medical Hyperthermia Device IV 1.0. The questionnaire will be administered at three predefined milestone timepoints to capture both early user experience and experience after familiarity with the device has been established.

Time frame: 8 months

To evaluate the short-term clinical effectiveness of the treatment administered by the Eight Medical Hyperthermia System IV 1.0.

The short-term clinical effectiveness will be assessed via: Cystoscopy assessment performed 3 months (± 1 week) after the first instillation. This assessment will be used to evaluate treatment response and clinical improvement.

Time frame: 3 months

To evaluate the short-term clinical effectiveness of the treatment administered by the Eight Medical Hyperthermia System IV 1.0.

The short-term clinical effectiveness will be assessed via: Cystoscopy assessment performed at 6 months (± 1 week) after the first instillation. This assessment will be used to evaluate treatment response and clinical improvement.

Time frame: 6 months

To evaluate the short-term clinical effectiveness of the treatment administered by the Eight Medical Hyperthermia System IV 1.0.

The short-term clinical effectiveness will be assessed via: Determining the number of participants requiring additional treatment by month 8 (± 1 week), such as: Repeat TURBT for recurrence, referral for cystectomy, and other clinically driven escalations.

Time frame: 8 months