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

NCT04845867 | Recruiting

• 1 other identifier: HEDOS-2021
• Study Type: observational
• Target: 1,470
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Specificity

  within 48 hours following thyroid surgery

• Safety of the use of ISAR-M THYRO

  1 month

Study Arms (1)

Measurement and digital documentation

continuous measurement and digital documentation with alarms and display off

Device: ISAR-M THYRO

Interventions

ISAR-M THYRO DEVICE

A diagnostic device for early detection of haemorrhage following thyroid surgery

Measurement and digital documentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Intended use of drains

Sponsors & Collaborators

• ISAR-M GmbH: lead
• CRI-The Clinical Research Institute GmbH: collaborator

Study Sites (1)

Krankenhaus Agatharied

Hausham, 83734, Germany

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Markus MA Albertsmeier, Dr.

  Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,

  STUDY CHAIR

Central Study Contacts

Olivia Fedunik-Brehm

CONTACT

+491735667761; olivia.fedunik-brehm@isar-m.com

Sabrina Koschel

CONTACT

+49 89 9901649975; hedos@cri-muc.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: October 23, 2023
• Primary Completion: October 23, 2024
• Study Completion: November 24, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

DE (1)