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

Launched by ISAR-M GMBH · Apr 13, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on improving the detection of serious bleeding after thyroid surgery. Normally, some patients may experience bleeding that can be dangerous, especially within the first two days after the operation. The trial is looking at a new method that continuously measures pressure in the neck area after surgery. By doing this, doctors hope to catch any increase in pressure early, which could signal bleeding before patients notice any symptoms. This early detection could help doctors take action more quickly, potentially reducing the risk of serious complications, such as brain damage or even death.

To participate in the trial, individuals must be at least 18 years old and scheduled to undergo thyroid surgery, like a total or partial removal of the thyroid gland. Participants will need to provide consent and cannot be using drains as part of their treatment. Those who join the study can expect to have their neck pressure monitored continuously after surgery, which will help researchers understand how effective this new method is at preventing serious complications from bleeding.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years.
• • Indication for thyroid surgery (e.g. total thyroidectomy, subtotal resection, partial resection or lobectomy) in routine clinical care according to applicable medical guidelines using all adequate surgical approaches.
• • Signed informed consent
• Exclusion Criteria:
• • - Intended use of drains