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Article History

Received: 25 March 2026

Accepted: 2 July 2026

First Online: 7 July 2026

Declarations

:

: The TESCO study (CLV-01-TES HT, protocol version 1.1 for the interim phase) was approved by Comitato Etico Campania 3 (opinion CLV-01-TES HT; minutes no. 10/24 dated 24 June 2024; Protocol No. 00026087 dated 23 July 2024). The study was conducted in accordance with the Declaration of Helsinki and applicable regulatory requirements. Written informed consent was obtained from all participants prior to enrollment. The study was registered on ClinicalTrials.gov (Identifier: NCT07490418; registered on 23 March 2026).

: Not applicable.

: FA is an employee of B&B s.r.l. and is responsible for the clinical development and regulatory activities related to TES HT100. B&B s.r.l. sponsored the study and holds intellectual property rights, including patents, related to the investigated device/technology. IC received consultancy fees from B&B s.r.l. for scientific support in the analysis and interpretation of the study data. All remaining authors declare that they have no competing interests.