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

Thyroid HEmorrhage DetectOr 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 fine-tune necessary actions during the rescue procedure based on objective pressure values, e.g. the decision to open cutaneous sutures immediately or later in the operation theatre, and therefore reduce additional perioperative morbidity and increase patients' safety.

Study Overview

• Status: Recruiting
• Conditions: Thyroid
• Intervention / Treatment: Device: ISAR-M THYRO

• Study Type: Observational
• Enrollment (Estimated): 1470

Contacts and Locations

• Study Contact: Name: Olivia Fedunik-Brehm; Phone Number: +491735667761; Email: olivia.fedunik-brehm@isar-m.com
• Study Contact Backup: Name: Sabrina Koschel; Phone Number: +49 89 9901649975; Email: hedos@cri-muc.eu

Study Locations

• Germany
  • Hausham, Germany, 83734
    • Recruiting
    • Krankenhaus Agatharied
    • Contact: Thomas TA von Ahnen, Dr.; Phone Number: +49 802 6393 4352; Email: thomas.ahnenvon@khagatharied.de
    • Contact: Peter PB Busch, Dr.; Phone Number: +49 8026 393 4428; Email: peter.busch@khagatharied.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HEDOS will enrol and measure presumably 1,470 eligible adult patients and follow each of them for 1 month, assuming that 22 cases of clinically relevant haemorrhage within 48 hours following thyroid surgery will be observed. It will be conducted in Germany and Austria with about 50 clinical sites participating.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Measurement and digital documentation; continuous measurement and digital documentation with alarms and display off	Device: ISAR-M THYRO; A diagnostic device for early detection of haemorrhage following thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity	detection of clinically relevant haemorrhage compared to the gold standard of detection in routine clinical care using 15 mmHg as cut-off	within 48 hours following thyroid surgery
Sensitivity and specificity	Sensitivity and specificity of detection of clinically relevant haemorrhage within 48 hours following thyroid surgery compared to the gold standard of routine clinical care detection in a three-level decision system using 10 and 20 mmHg as cut-offs	within 48 hours following thyroid surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	Specificity as well as positive and negative predictive values of detection of clinically relevant haemorrhage within 48 hours following thyroid surgery compared to the gold standard of detection in routine clinical care using the two-level and the three-level decision system.following thyroid surgery compared to the gold standard of routine clinical care detection in routine clinical care using the two-level and three-level decision system	within 48 hours following thyroid surgery
Safety of the use of ISAR-M THYRO	Safety of the use of ISAR-M THYRO by means of adverse events within 1 month following thyroid surgery	1 month

Collaborators and Investigators

• Sponsor: ISAR-M GmbH
• Collaborators: CRI-The Clinical Research Institute GmbH
• Investigators: Study Chair: Markus MA Albertsmeier, Dr., Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): October 23, 2024
• Study Completion (Estimated): November 24, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: HEDOS-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No