Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
NCT ID: NCT02862899
Last Updated: 2017-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2015-01-31
2016-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Heating cable
Thermowire
Interventions
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Thermowire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With scheduled hyperthermic intraperitoneal chemotherapy (HIPEC) because of known peritoneal disease (primary or secondary)
* Who have provided written consent
Exclusion Criteria
* Persons under 18 years old
* Pregnant or breast-feeding women
* Allergy to latex
* Abandon of HIPEC following surgical exploration
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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ORTEGA 2012
Identifier Type: -
Identifier Source: org_study_id
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