Thyroid Hemorrhage Detector Study Using ISAR-M THYRO Device for Early Detection After Thyroid Surgery

What this Trial Is About

Researchers are studying the use of a diagnostic device called ISAR-M THYRO to detect bleeding early after thyroid surgery. Postoperative bleeding occurs in 0.6 to 4% of patients, with most cases happening within the first 48 hours and potentially leading to serious complications or death. The study aims to improve early detection by continuously measuring neck pressure, which may indicate bleeding earlier than current symptom-based methods. Participants will have the ISAR-M THYRO device applied after thyroid surgery to continuously measure and digitally document neck pressure for up to 48 hours. The device includes alarms and a display that can be turned off. This observational study focuses on collecting data to assess the device's ability to detect bleeding early through pressure monitoring during the critical postoperative period. During the study, participants will be monitored for neck pressure changes using the device, and researchers will evaluate the sensitivity and specificity of bleeding detection within 48 hours after surgery. Safety of the device will be assessed for one month. The study helps understand if continuous pressure monitoring can provide timely alerts to reduce serious complications after thyroid surgery.

A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product