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OpenTrials
Completed

NCT Number: NCT02862899

Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermowire

Device

Other names: Heating cable

Primary outcomes

  1. SAE due to use of Thermowire

    Time frame: Through study completion up to 22 months

    In particular visceral thermal lesions or electric accidents.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CHIPOFIL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2016
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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