search
Back to results

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
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intraperitoneal Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
August 5, 2016
Last Updated
April 13, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
search

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

We'll reach out to this number within 24 hrs