Ricerca Progetti nazionali, regionali, internazionaliEndoLight

Endoscopio luminoso per il trattamento dell'Helicobacter pylori

This project aims to develop and test a prototype medical device for the eradication of gastric Helicobacter pylori (H. pylori) infection, based on the use of visible light as a therapeutic agent. The infection associated with H. pylori is one of the most prevalent in the world, with an average prevalence in Italy of 50%. Of the patients for whom eradication with antibiotic therapy is indicated, 20-25% do not resolve due to antibiotic resistance, burdening the healthcare system without being able to receive resolving treatment.

The efficacy of visible light phototherapy on in vitro models of H. pylori is widely demonstrated in the literature and is based on the presence in the bacterium of molecules (porphyrins) that mediate photoreactions associated with the production of reactive species that kill the bacterium if produced in sufficient quantities, depending on the light dose received.

In this context, it is crucial to solve the problem of light transmission inside the gastric cavity in a minimally invasive manner. In this respect, the project leader (Probiomedica Srl) has developed experience in the field of phototherapy sources, identifying the best wavelengths that maximise the effectiveness of intragastric phototherapy, also thanks to a strong interaction with the SBSC-UNIFI partner from which the company was born. Starting from the idea that routine diagnostic practices allow access to the inside of the stomach, this project wants to exploit video gastroscopes as a means of conveying therapeutic light therapeutic light into the gastric cavity, proposing to realise an illuminator consisting of a thin optical fibre optical fibre to be inserted inside the gastroscope and coupled with external light sources.

This takes full advantage of the protocols and specialised personnel already in place (gastroenterologist endoscopist), with minor modifications due to the need to insert the fibre into the gastroscope and the training of personnel for its use.

The fibre system will be designed, realised and characterised thanks to the knowledge of biophotonics and medical physics of the IFAC-CNR and SBSC-UNIFI partners. The power supply and external will be realized thanks to the contribution of partner PCE.

Once the device is assembled, any undesirable effects of illumination (e.g. possible heating of the tissue) will be studied with special tests on artificial models and ex-vivo samples of the stomach. To demonstrate the effectiveness of the device, the Valdisieve partner will coordinate the final clinical phase, in which a pilot clinical trial will be designed and performed on a small cohort of patients.

 

Costo totale progetto:

Responsabile: Maria Rosa Biagini

Data inizio: 01.03.22

Data conclusione: 22.03.24

CUP n. D14E20006320009.      

Progetto finanziato dalla Regione Toscana nell’ambito del PROGRAMMA OPERATIVO REGIONALE FESR 2014 – 2020, Bando 2: Progetti di ricerca e sviluppo delle MPMI

 

Partner	Ruolo	Costo complessivo	Contributo ammissibile complessivo	Costo singolo	Contributo ammissibile singolo
PROBIOMEDICA S.R.L.	Capofila	761.926,03	330.225,97	66.202,41	29.791,08
CONSIGLIO NAZIONALE DELLE RICERCHE ISTITUTO DI FISICA APPLICATA “NELLO CARRARA” - IFAC	Partner			109.072,50	49.082,63
VALDISIEVE HOSPITAL S.R.L.	Partner			252.815,00	101.126,00
Università degli Studi di Firenze - Dipartimento di Scienze Biomediche Sperimentali e Cliniche "M. Serio"	Partner			103.506,42	46.577,89
P.C.E. COMPUTER SYSTEM S.R.L.	Partner			230.329,70	103.648,37