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Bioimpedance Variation of Free Flap for After Clamping (MONITRANS)

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ClinicalTrials.gov Identifier: NCT03118115
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

MONITRANS project consist of developing a monitoring technology of post-operative breast reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by monitoring patients at home.

Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water intake in the plasma compartments. The investigator would like to prove, by this research project, that they are able to detect ischemia via bioimpedance technology.

During abdominal free flap harvesting for breast reconstruction, there are few minutes where the flap is clamped because of anastomosis on the recipient vessels. The investigators would seize the opportunity of this step, which is similar to vascular thrombosis, to measure bioimpedance variations.

Therefore they would like to measure variations of the flap bioimpedance before and after vascular section. Another purpose consists of developing an algorithm which will detect postoperative thrombosis.


Condition or disease Intervention/treatment Phase
Thrombosis Device: Measurement of the flap bioimpedance Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bioimpedance Variation of Free Flap for After Clamping - MONITRANS
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : December 22, 2017
Estimated Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Impedance
Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.
Device: Measurement of the flap bioimpedance
Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.




Primary Outcome Measures :
  1. Measurement of impedence [ Time Frame: 1 day ]
    Measurement of the flap bioimpedance before and after clamping of the artery or the vein.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient suitable for a abdominal perforator based flap breast reconstruction
  • age over 18 years old

Exclusion Criteria:

  • pregnancy
  • women with active pacemaker implant or artificial heart

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118115


Contacts
Contact: Raphaël SINNA, MD, PhD +33 3 22 08 90 04 sinna.raphael@chu-amiens.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Raphaël SINNA, MD, PhD    +33 3 22 08 90 04    sinna.raphael@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Raphaël SINNA, MD, PhD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03118115     History of Changes
Other Study ID Numbers: PI2016_843_0028
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
bioimpedance
thrombosis
free flap
microsurgerie
breast reconstruction

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases