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Article History

Received: 12 January 2025

Revised: 17 August 2025

Accepted: 5 September 2025

First Online: 19 September 2025

Declarations

:

: The clinical trial was conducted in accordance with international standards of good clinical practice: International Conference on Harmonization guidelines, Declaration of Helsinki, European Regulation (EU) 536/2014, ISO-14155:2020 Clinical investigation for medical devices for human subjects and Regulation (EU) 2017/745 of the European Parliament and National Royal Decree (1090/2015). The clinical protocol was approved by Dexeus University Hospital Ethics Committee. None of the investigators were members of the Ethics Committee.All procedures performed in the study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.The authors declare that they have not used artificial intelligence (AI) or any tool that uses AI in the writing of this article.

: Informed consent was obtained from all individual participants included in the study.

: The clinical trial was authorized by the Spanish Agency for Drugs and Medical Devices (AEMPS—Agencia Española de Medicamentos y Productos Sanitarios) under clinical investigation plan (CIP) STELLA 2021, nº 954/21/EC-R. The Clinical Trial was registered with the Number NCT06744829.Ep22800309nwa1. Publication: 04.09.2024. Bulletin: 2024/36. Application number: 22800309.1. Filing date: 19.10.2022. Device currently patented in Europe, United States, Brazil and India.

: All authors are part of the Stella®-IGB Clinical Trial research group, and have received fees from Mikromic Medical, S.L. company for the performance of the endoscopic procedures and the follow-up of patients.