Breast ReconstructionMONITRANS2NCT05710705
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
A study testing portable prototype of bioimpedance measurement in people with Breast Reconstruction and Thrombosis, Venous, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity
- What is being tested?
- portable prototype of bioimpedance measurement
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman undergoing microsurgical breast reconstruction using a free abdominal flap
- Age greater than or equal to 18 years
Who cannot join
- Pregnant patient
- Patient with an active implantable device such as a pacemaker or an artificial heart
- Patient refusing to participate in the study
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Raphaël SINNA, MD, PhD, +33 3 22 08 90 04, sinna.raphael@chu-amiens.fr
About this study
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.
The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.
This protocol is therefore a feasibility study for the collection of data of interest.
- Being tested
- portable prototype of bioimpedance measurement
- Keywords
- breast reconstruction, Thrombosis, Venous, bioimpedance measurement capacity
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable prototype of bioimpedance measurementDevice
The device will be installed during the patient's operation. It will be attached to the healthy skin of the flap (without wound or scar) by sterile glue. It will then be covered with a self-adhesive "tegaderm" type dressing. The wound will be isolated from the device with a hermetic silicone dressing of the "Mepilex" type, for example. There will therefore be no communication between the measuring device and the surgical wound.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of impedence
Impedence measurement during episode of ischemia.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start8 Dec 2022
- Primary completion27 Dec 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710705
- Sponsor's protocol ID
- PI2022_843_0040
- Acronym
- MONITRANS2
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05710705
- Acronym / sponsor ID
- MONITRANS2 / PI2022_843_0040
- Keywords
- breast reconstruction, Thrombosis, Venous, bioimpedance measurement capacity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2023 (actual)
- 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.
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.
The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.
This protocol is therefore a feasibility study for the collection of data of interest.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woman undergoing microsurgical breast reconstruction using a free abdominal flap
- Age greater than or equal to 18 years
Key exclusion criteria (4 listed)
- Pregnant patient
- Patient with an active implantable device such as a pacemaker or an artificial heart
- Patient refusing to participate in the study
- Age less than 18 years old
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 |
|---|---|---|
| portable prototype of bioimpedance measurementThe device will be installed during the patient's operation. It will be attached to the healthy skin of the flap (without wound or scar) by sterile glue. It will then be covered with a self-adhesive "tegaderm" type dressing. The wound will be isolated from the device with a hermetic silicone dressing of the "Mepilex" type, for example. There will therefore be no communication between the measuring device and the surgical wound. | Device | – |
Primary outcome
Measurement of impedence
Time frame: one day
Impedence measurement during episode of ischemia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portable prototype of bioimpedance measurement in people with Breast Reconstruction and Thrombosis, Venous, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael SINNA, Pr (03 22 08 90 04, sinna.raphael@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of impedence (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.