NCT02862899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

August 5, 2016

Last Update Submit

February 5, 2026

Conditions

Intraperitoneal Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • SAE due to use of Thermowire

    In particular visceral thermal lesions or electric accidents.

    Through study completion up to 22 months

Study Arms (1)

Heating cable

EXPERIMENTAL
Device: Thermowire

Interventions

ThermowireDEVICE
Also known as: Heating cable
Heating cable

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Persons under guardianship
  • Persons under 18 years old
  • Pregnant or breast-feeding women
  • Allergy to latex
  • Abandon of HIPEC following surgical exploration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

  • 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.

    PMID: 31667330RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 11, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(1)