Well-Confined Mucosal LasEr Ablation with a Negative Pressure Based Endoscopy Capsule

Project Information

CLEAN

Grant agreement ID: 835907

DOI

10.3030/835907

Project closed

EC signature date 22 March 2019

Start date 1 April 2019

End date 31 March 2021

Funded under

• EXCELLENT SCIENCE - Marie Skłodowska-Curie Actions

Total cost

€ 157 355,52

EU contribution

€ 157 355,52

Coordinated by

IZMIR BIYOTIP VE GENOM MERKEZI
Türkiye

Periodic Reporting for period 1 - CLEAN (Well-Confined Mucosal LasEr Ablation with a Negative Pressure Based Endoscopy Capsule)

Reporting period: 2019-04-01 to 2021-03-31

Summary of the context and overall objectives of the project

Many gastrointestinal tract diseases usually begin in superficial tissues, such as oesophageal cancer originating as precancerous mucosal lesions and then spreading through deeper tissue structures. For example, Barrett’s oesophagus is a precancerous oesophagus condition and is associated with oesophageal adenocarcinoma. The incidence of oesophageal carcinoma has increased ~6-fold over the past two decades and has become the eighth most common cancer worldwide. The treatment of the critically important Barrett's oesophagus is carried out with endoscopic interventions. However, the challenge associated with current deployments of endoscopic interventions is that the depth of therapy is typically induced at a fixed distance, resulting in a profound therapeutic effect or insufficient depth of the therapeutic effect. Consequently, there is a need for an endoscopy device that removes abnormal mucosa tissue layer in a safe, efficient, single-session, and reliable manner over large areas.
The objective of the CLEAN Project is to develop a novel endoscopic capsule design and to build a prototype endoscopy system using this capsule, which provides local coagulation to the superficial layer of target mucosal tissue with sufficient depth to remove abnormal tissue. However, this depth will be shallow enough to avoid the residual effects of therapy within deeper tissue layers.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

CLEAN Project was a multidisciplinary research programme that integrates technology research and development with ex-vivo tissue studies. The research program was completed in three specific steps that support and complement the Project's purpose. The first step was to develop a computer modelling that would mimic the thermal dynamics of the capsule. Computer modelling characterized the total heat energy required to successfully coagulate the mucosal layer, adequate sliding speed of the capsule along the oesophagus, sufficient therapy time for effective coagulation, and the amount of thermal damage in the deeper oesophagus layers. The second step was to develop the configuration of the capsule in a computer-aided design program. This original design extended the target layer above and away from its underlying layers to achieve a well-confined therapeutic effect by delivering vacuum force. With the confinement of therapeutic effect, it was aimed that deeper tissue structures are partially separated from the coagulation region. The third step was to construct and optimize a prototype-level endoscopy system for pre-clinical ex-vivo tissue trials. A high power, 1380-nm diode laser was utilized for the therapeutic photothermal coagulation. The final step was to investigate the feasibility of the design and evaluate the performance of the prototype system in an ex-vivo sheep oesophagus model. Tissue samples were collected for histology examination to validate the performance objective of the Project.
The capsule design thrived performed laser-induced coagulation in the mucosa and sub-mucosa layers according to the results obtained. In an ex-vivo sheep oesophagus model, there was no significant thermal damage to deep muscle tissues.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In the CLEAN Project, a new endoscopy capsule design was developed, and a prototype endoscopy system using this capsule design for ex-vivo photothermal mucosa coagulation was built. Interestingly, it will be possible with our technology to extend the same concept to other endoscopy therapy applications, such as colon polyps. The project brought three innovative perspectives: (i) Well-limited therapeutic depth. (ii) Ability to scan a large mucosal surface in a single session. (iii) Therapeutic capsule design that can be combined in diagnostic applications.
The Project acquired new knowledge and technology to give researchers the necessary new tools for safe, consistent, and reliable coagulation of superficial abnormal tissue layers using straightforward and practical design, thus directly influencing pre-clinical and clinical studies in gastroenterology.

Experimental setup. The capsule was processed from biocompatible material.