Non-muscle Invasive Bladder Cancer (NMIBC)NCT07758881
Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
A study testing Hyperthermic intravesical chemotherapy (HIVEC) in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Eight Medical International BV at 2 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Hyperthermic intravesical chemotherapy (HIVEC)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
AZ Sint-Jan, Campus Sint-Jan
Bruges, 8000
AZ Delta
Roeselare, 8800
About this study
Official 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)
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:
Read more
- 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.
- Being tested
- Hyperthermic intravesical chemotherapy (HIVEC)
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intravesical chemotherapy (HIVEC)Device
Hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) using the Eight Medical Hyperthermia System IV 1.0
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Device performance will be assessed during each instillation by determining: Adverse events as a result of device malfunction in patients, users, or other persons.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 1 (week 1)
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 1 (week 1)
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 6 (week 6)
To evaluate the Quality of Life of study participants treated with the EightMedical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 6 (week 6)
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 8 (3 months after first instillation)
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 8 (3 months after first instillation)
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 11 (6 months after first instillation)
To evaluate the Quality of Life of study participants treated with the Eight Medical Hyperthermia System IV 1.0.
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.
Measured: During treatment visit 11 (6 months after first instillation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eight Medical International BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758881
- Sponsor's protocol ID
- IMPROVER
- Other IDs
- CIV-26-03-056891
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07758881
- Acronym / sponsor ID
- IMPROVER
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eight Medical International BVIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermic intravesical chemotherapy (HIVEC)Hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) using the Eight Medical Hyperthermia System IV 1.0 | Device | – |
Primary outcome
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.
16 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.
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).
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).
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).
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).
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
To evaluate the short-term clinical effectiveness of the treatment administered by the Eight Medical Hyperthermia System IV 1.0.
Time frame: 3 months
To evaluate the short-term clinical effectiveness of the treatment administered by the Eight Medical Hyperthermia System IV 1.0.
Time frame: 6 months
To evaluate the short-term clinical effectiveness of the treatment administered by the Eight Medical Hyperthermia System IV 1.0.
Time frame: 8 months
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermic intravesical chemotherapy (HIVEC) in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Eight Medical International BV at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Archer Research (+32 11286948, info@archerresearch.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.