A Prospective Study Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
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)
2 other identifiers
interventional
30
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2027
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 11, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
August 11, 2026
August 1, 2026
1.4 years
August 3, 2026
August 6, 2026
Conditions
Outcome Measures
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.
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.
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 (16)
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.
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).
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.
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).
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.
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).
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.
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).
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.
8 months
- +11 more secondary outcomes
Interventions
Hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) using the Eight Medical Hyperthermia System IV 1.0
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AZ Sint-Jan, Campus Sint-Jan
Bruges, 8000, Belgium
AZ Delta
Roeselare, 8800, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2026
First Posted
August 11, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
August 11, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share