Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

Intraperitoneal Chemotherapy Clinical Trial

— CHIPOFIL  

Official title:

Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862899
• Other study ID #: ORTEGA 2012
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: April 13, 2017
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Intraperitoneal Chemotherapy

Intervention

Device:
• Thermowire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAE due to use of Thermowire	In particular visceral thermal lesions or electric accidents.	Through study completion up to 22 months