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NCT Number: NCT07758881

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.

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Key information

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC) Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan, Campus Sint-Jan, Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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.

Exclusion criteria

  • 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.
  • Gross hematuria that precludes safe catheterization or intravesical therapy.
  • 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.
  • Urethral strictures or other anatomical/functional conditions that complicate or prevent safe catheterization.
  • Known vesico-ureteral reflux that increases risk with intravesical chemotherapy.
  • Inability to remain in the supine position for at least 60 minutes.
  • 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.
  • 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 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.
  • 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.

Treatment and study plan

Hyperthermic intravesical chemotherapy (HIVEC)

Device

Hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) using the Eight Medical Hyperthermia System IV 1.0

Primary outcomes

  1. 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.

    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)

    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.

Secondary outcomes

  1. 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.

    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).

    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.

  2. 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.

    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).

    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.

  3. 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.

    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).

    Device performance will be assessed during each instillation by determining: Adverse events as a result of device malfunction in patients, users, or other persons.

  4. 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.

    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).

    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.

  5. 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.

    Time frame: 8 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 8 months

    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.

  9. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 1 (week 1)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) questionnaire (general cancer quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, and a high score for the global health status / QoL represents a high QoL.

  10. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 1 (week 1)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24) questionnaire (disease-specific quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  11. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 6 (week 6)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) questionnaire (general cancer quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, and a high score for the global health status / QoL represents a high QoL.

  12. To evaluate the Quality of Life of study participants treated with the EightMedical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 6 (week 6)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24) questionnaire (disease-specific quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  13. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 8 (3 months after first instillation)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) questionnaire (general cancer quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, and a high score for the global health status / QoL represents a high QoL.

  14. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 8 (3 months after first instillation)

    Quality of Life will be evaluated through patient-reported outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24) questionnaire (disease-specific quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  15. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 11 (6 months after first instillation)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) questionnaire (general cancer quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, and a high score for the global health status / QoL represents a high QoL.

  16. To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.

    Time frame: During treatment visit 11 (6 months after first instillation)

    Quality of Life will be evaluated through Patient-Reported Outcomes (PROs), obtained via: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24) questionnaire (disease-specific quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Study contacts

Contact information is provided by the study sponsor or research team.

Archer Research

CONTACT

[email protected]

+32 11286948

Sponsors and collaborators

Lead sponsor

Eight Medical International BV

Industry

Registry information

Official study title

A Prospective, Single-arm, Interventional Study to Evaluate the Safety and Performance of the EIght Medical hyPeRthermia System IV 1.0, Used to Deliver Recirculating Hyperthermic Intravesical Chemotherapy (HIVEC) With Mitomycin C (MMC) for Treatment of Adult Patients With nOn-Muscle inVasive bladdER Cancer (NMIBC)

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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