Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy (CHIPOFIL)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Intraperitoneal Chemotherapy

Treatments: Device: Thermowire

Study type: Interventional

Funder types: Other

Identifiers

NCT02862899

ORTEGA 2012

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Heating cable

Experimental group

Treatment:

Device: Thermowire