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EXUCHECK

The ExuCheck project targets a breakthrough in early detection of one of the most common clinical complications, namely post-operative infection, based around an analytical device (measuring pH & lactate) and an algorithm for interpreting variations in the possible patient infection markers.



Published on 3 May 2021

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Smart Drain for Early Detection of Post-Operative Infection

The ExuCheck project targets a breakthrough in early detection of one of the most common clinical complications, namely post-operative infection, based around an analytical device (measuring pH & lactate) and an algorithm for interpreting variations in the possible patient infection markers.





 

Starting date : Jan. 2019 > Jun. 2020
 

Lifetime: 18 months


Program in support : EIT Health


 

Status project : complete


CEA-Leti's contact :

Véronique Mourier


 

Project Coordinator: Medtronic (UK)

Partners:  

  • FR: Bürkert, CEA-Leti, Maatel, Université Grenoble Alpes
  • NL: Erasmus Universiteit Medisch Centrum Rotterdam


​Target market: n/a


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Investment:  € 0.7 m.

EC Contribution: € 0.7 m.


Stakes

  • CEA-Leti had formerly developed micro-electrochemical sensors for measuring pH and lactic acid.

  • CEA-Leti’s principal aims within the Exucheck project
    • The lactic acid sensor developed by CEA-Leti performed acceptably, however it had only been assessed in laboratory conditions and in model solutions (e.g. PBS). CEA-Leti’s principal project aim involves ensuring full lactic acid sensor compatibility with the application by:
    > Ensuring sensor compatibility with sterilization (e.g. gamma radiation)
    > Assessing sensor robustness to interferent species present in the exudates
    > Assessing sensor biocompatibility
    > Ensuring at least 5 days functional stability, i.e. developing dedicated anti-biofouling layers
    > Testing the sensor in real exudates.
    • CEA-Leti anticipates developing the complete system. The main task involves integrating the existing pH and lactic acid sensors into a unique platform with suitable electrical and fluid connections prior to full platform characterization. This work will be performed in close collaboration with Maatel, which is developing the electronic and HMI parts.
    • CEA-Leti will be involved in preclinical testing on completion of the project. Here, our main role will be fabrication of dedicated sensor platforms.
    • CEA-Leti is contributing to the sensor industrialization plan along with the project industrial partners.

OBJECTIVES

  • Exucheck aims at providing a technological breakthrough in the early detection of one of the most common complications, post-operative infection, by detecting infection resulting from anastomosis leakage following colorectal surgery.

  • A new and innovative diagnosis approach has been developed based on a smart sensor system integrated within a drain to monitor in real-time relevant parameters related to infection. The identification of the presence of specific bacteria is not adapted for the targeted clinical application as too many different species are involved. The sensing device therefore focuses on two indirect biomarkers identified by previous studies led by ERASMUS and MEDTRONIC: pH and lactic acid concentration.

  • A first Proof of Concept with a drain integrated with a pH sensor has been developed jointly by CEA and MEDTRONIC.

  • The overall goal of the project is to bring the ExuCheck solution to an acceptable level of risk for further investments by MEDTRONIC, ensuring internal funding for the launch of large-scale clinical studies and industrialization.

  • Efforts are focused on developing the system until clinical trials are launched, assessing its ease of use and medicoeconomic impact.



IMPACT

  • In the short term: advancement of scientific knowledge through sharing research results with the scientific community.
    In the medium term: reducing project risks and preparing deployment (supply chain, business plan) to create a new MEDTRONIC range.
    In the long term: if the smart drain meets the clinical and commercial expectations, new generations of MEDTRONIC sensing systems may be considered, e.g. smart implants.