Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy (CHIPOFIL)
Primary Purpose
Intraperitoneal Chemotherapy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thermowire
Sponsored by
About this trial
This is an interventional other trial for Intraperitoneal Chemotherapy
Eligibility Criteria
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
Sites / Locations
- CHU Dijon Bourgogne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heating cable
Arm Description
Outcomes
Primary Outcome Measures
SAE due to use of Thermowire
In particular visceral thermal lesions or electric accidents.
Secondary Outcome Measures
Full Information
NCT ID
NCT02862899
First Posted
August 5, 2016
Last Updated
April 13, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02862899
Brief Title
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
Acronym
CHIPOFIL
Official Title
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraperitoneal Chemotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heating cable
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Thermowire
Other Intervention Name(s)
Heating cable
Primary Outcome Measure Information:
Title
SAE due to use of Thermowire
Description
In particular visceral thermal lesions or electric accidents.
Time Frame
Through study completion up to 22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
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