Intraperitoneal Chemotherapy
Conditions
Brief summary
The investigator will study the possibility of in situ heating of the liquid containing the chemotherapy, so as to avoid the need for an external pumping system with its complexity, and its associated risks and costs. The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS, which is in charge of its development) was patented and tested in pigs in two studies that included 15 animals altogether (in 7 of which the heating cable was used). The aim of the first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of the chemotherapy were evaluated in a second study. The results obtained justify transfer to use in humans in the context of a clinical trial so as to obtain CE certification.
Interventions
DEVICEThermowire
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with national health insurance cover * With scheduled hyperthermic intraperitoneal chemotherapy (HIPEC) because of known peritoneal disease (primary or secondary) * Who have provided written consent
Exclusion criteria
* Persons under guardianship * Persons under 18 years old * Pregnant or breast-feeding women * Allergy to latex * Abandon of HIPEC following surgical exploration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAE due to use of Thermowire | Through study completion up to 22 months | In particular visceral thermal lesions or electric accidents. |
Countries
France
Outcome results
None listed