Hyperthermic Intra-Vesical Chemotherapy
NCT06768346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 259
Last updated 2025-01-10
Summary
The purpose of the HIVEC II trial is to find out if the combination of the new technology called hyperthermia (the use of heat) and a drug called mitomycin is more effective than mitomycin alone which is the standard treatment for bladder cancer in reducing the chances of bladder cancer returning.
Conditions
Interventions
- DEVICE
-
Hyperthermia will be delivered in combination with each instillation using the Combat BRS system
The Combat BRS system is a temperature controlled fluid recirculation system for the delivery of hyperthermic intravesical chemotherapy. The chemotherapy fluid is circulated in a closed system and warmed by an external isolated dry system using a novel innovative laminated aluminium foil heat exchanger with a small priming volume.
Sponsors & Collaborators
-
Queen Mary University of London
lead OTHER
Principal Investigators
-
Dr John Kelly · Queen Mary University of London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-08
- Primary Completion
- 2020-05-27
- Completion
- 2020-05-27
Countries
- United Kingdom
Study Locations
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