Clinical assessment of the realized device on patients is scheduled in the last year of the project.
The achievement of this main objective implies the accomplishment of the following sub-objectives:
- development of optical fiber sensor for the measurement of pH,
- development of the optical fiber sensor for bile detection,
- development of the optical fiber manometer,
- integration of the optical fiber sensors within a single catheter,
- realization of the portable interrogation unit for all the three parameters,
- clinical assessment of the final device on both volunteers and patients.
The OPTIMO sensor based on an all-optical technology offers the possibility of performing the measurement of the three parameters simultaneously by means of a single or combined catheter.
It would be definitely an innovative product in the gastroesophageal diagnostic scenario with high potential for worldwide market penetration and application developments.
The target of the present proposal is the design, implementation and characterization of a portable device based on an all-optical technology capable to perform simultaneously esophageal manometry, pH-metry and bilimetry.
It will provide physicians a compact and reliable tool to perform exhaustive diagnosis in gastroesophageal reflux pathologies.
Pressure measurement along the esophagus is performed with an array of optical fiber gratings, which ensures the monitoring along a length of about 30 cm with high spatial resolution.
The sensors for the measurement of pH and bile are based on the change of absorption caused by the parameter under investigation.
In the case of pH, an acid-base indicator that changes its absorption as a function of pH is immobilized on controlled pore glasses suitable coupled to plastic optical fibers.
As for bile detection, the measurement is based on the direct absorption of bilirubin, the main biliary pigment, and a bundle of plastic optical fibers carries the signal.
The main objective of the Photonic Sensing transnational call for R&D project proposals is to contribute to the fast development and implementation of photonics based sensing technologies.
This proposal deals with medical applications and more specifically in the development of a point-of-care (POC) device completely based on optical technology, which will constitute a huge step-forward in the monitoring of gastroesophageal refluxes.
This new device will provide physicians with a novel and reliable tool that will help them in the formulation of the correct diagnosis in gastroesophageal reflux disease, which affects between 10% and 20% of the population in western world.
The proposed project foresees to evaluate the performance of the final device on volunteers and to start the clinical assessment on patients, therefore reaching a technology readiness level (TRL) of 6, from a starting TRL of 2.