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

NCT07758881 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

DEVICE

Hyperthermic intravesical chemotherapy (HIVEC)

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

Sponsors & Collaborators

  • Eight Medical International BV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758881 on ClinicalTrials.gov