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Article History

Received: 9 May 2025

Accepted: 14 July 2025

First Online: 21 July 2025

Declarations

:

: This study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)—Good Clinical Practice (GCP), and ISO 14155:2020 GCP standards. The Institutional Ethics Committee of Dixit Hospital approved the study prior to initiation (IEC approval letter; IEC/JAN/2025). Due to the retrospective and observational nature of the study, there was no direct intervention and modification of the patient’s treatment; therefore, the ethics committee waived the informed consent.

: Not applicable.

: Kiran Kumar Shetty and Roopesh Poojary are employees of Meril, Vapi, India, the manufacturer of the medical device evaluated in this study. Their involvement was restricted to providing technical input regarding the device, assistance with study methodology, and editorial support during manuscript preparation. They did not participate in clinical decision-making, data collection, or analysis. All other authors declare no conflicts of interest.