Intraperitoneal ChemotherapyCHIPOFILNCT02862899
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
A study testing Thermowire in people with Intraperitoneal Chemotherapy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraperitoneal Chemotherapy
- What is being tested?
- Thermowire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persons under guardianship
- Persons under 18 years old
- Pregnant or breast-feeding women
- Allergy to latex
- Abandon of HIPEC following surgical exploration
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Intraperitoneal Chemotherapy
- Being tested
- Thermowire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermowireDevice
Also called Heating cable
| Study group | Role | What they receive |
|---|---|---|
| Heating cable | Experimental | Not described Receives: Device: Thermowire |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE due to use of Thermowire
In particular visceral thermal lesions or electric accidents.
Measured: Through study completion up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraperitoneal ChemotherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862899
- Sponsor's protocol ID
- ORTEGA 2012
- Acronym
- CHIPOFIL
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2016
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
Ortega-Deballon P, Facy O, Binquet C, Delroeux D, Rat P. CHIPOFIL: A pilot study assessing the feasibility of HIPEC without extracorporeal circuit. Pleura Peritoneum. 2019 Jul 26;4(3):20190008. doi: 10.1515/pp-2019-0008. eCollection 2019 Sep 1.
PubMed 31667330
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT02862899
- Acronym / sponsor ID
- CHIPOFIL / ORTEGA 2012
- Conditions
- Intraperitoneal Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heating cable | Experimental | Device: Thermowire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Persons under guardianship
- Persons under 18 years old
- Pregnant or breast-feeding women
- Allergy to latex
- Abandon of HIPEC following surgical exploration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermowireAlso: Heating cable | Device | Heating cable |
Primary outcome
SAE due to use of Thermowire
Time frame: Through study completion up to 22 months
In particular visceral thermal lesions or electric accidents.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 31667330Ortega-Deballon P, Facy O, Binquet C, Delroeux D, Rat P. CHIPOFIL: A pilot study assessing the feasibility of HIPEC without extracorporeal circuit. Pleura Peritoneum. 2019 Jul 26;4(3):20190008. doi: 10.1515/pp-2019-0008. eCollection 2019 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermowire in people with Intraperitoneal Chemotherapy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAE due to use of Thermowire (time frame: Through study completion up to 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.