Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

Not Applicable

Completed

• Conditions: Intraperitoneal Chemotherapy
• Interventions: Device: Thermowire

• Registration Number: NCT02862899
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heating cable	Thermowire	-

Primary Outcome Measures

Name	Time	Method
SAE due to use of Thermowire	Through study completion up to 22 months	In particular visceral thermal lesions or electric accidents.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France