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Study identifier: NCT04845867 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Thyroid  ·  Sponsor: ISAR-M GmbH

PhaseN/A
Planned participants1470
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

After thyroid surgery, 0.6 to 4% of patients develop postoperative bleeding. 90% of this postoperative bleeding occurs within the first 48 hours. Most of the time, the complications are rapidly progressing and require immediate attention. Up to 0.6% of patients with postoperative bleeding die. In a clinical study with postoperative pressure measurements it could be shown that postoperative bleeding without interruption leads to a continuous increase in pressure in the neck, as is observed when coughing and pressing. Systematic invasive pressure measurement in the thyroid compartment after surgery might detect a continuous increase in pressure which is often caused by a growing haematoma, indicating serious post-surgery bleeding at a much earlier time compared to state of the art diagnostic workflow. n routine clinical care, detection of serious haemorrhage depends on the patients alerting symptoms even if post-operative intermittent monitoring of vital parameters and wound conditions is performed according to current medical guidelines and local instructions. Device-based, continuous haemorrhage detection within 36 to 48 hours after surgery would allow to objectively measure an increase in cervical pressure before symptoms occur, i.e. early detection of risk leading to timely therapeutic actions. Thus, the risk of serious complications like hypoxic brain damage and death caused by post-operative haemorrhage is minimized. In addition, the intervention team would be able to fin…

This description comes directly from the study's public registry record.

Talk to the study team

Olivia Fedunik-Brehm  ·  +491735667761  ·  olivia.fedunik-brehm@isar-m.com

Sabrina Koschel  ·  +49 89 9901649975  ·  hedos@cri-muc.eu

Always discuss trial participation with your own doctor first.

Locations (1)

Krankenhaus AgathariedHausham, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT04845867