ThyroidHEDOSNCT04845867
A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product
An observational study of Thyroid, run by ISAR-M GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid
- What is being tested?
- ISAR-M THYRO
- Type of treatment
- Medical device
- How many people
- 1,470 participants
- Where
- 1 siteGermany
- Study dates
- 23 Oct 2023to 24 Nov 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Intended use of drains
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Krankenhaus Agatharied
Hausham, 83734
Thomas TA von Ahnen, Dr., +49 802 6393 4352, thomas.ahnenvon@khagatharied.de
Peter PB Busch, Dr., +49 8026 393 4428, peter.busch@khagatharied.de
About this study
Official title: 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.
- Conditions
- Thyroid
- Being tested
- ISAR-M THYRO
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISAR-M THYRODevice
A diagnostic device for early detection of haemorrhage following thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Measurement and digital documentation | continuous measurement and digital documentation with alarms and display off Receives: Device: ISAR-M THYRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 48 hours following thyroid surgery
Secondary outcomes (2)
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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start23 Oct 2023
- Primary completion23 Oct 2024 (estimated)
- Study completion24 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,470 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- ISAR-M GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRI-The Clinical Research Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Markus MA Albertsmeier, Dr., Study chair, Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845867
- Sponsor's protocol ID
- HEDOS-2021
- Acronym
- HEDOS
- Status last verified
- Jul 2024
- First submitted
- 13 Apr 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid HEmorrhage DetectOr Study
- ClinicalTrials.gov ID
- NCT04845867
- Acronym / sponsor ID
- HEDOS / HEDOS-2021
- Conditions
- Thyroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,470 participants (estimated)
- Lead sponsor
- ISAR-M GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CRI-The Clinical Research Institute GmbH
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2024 (estimated)
- Study completion
- 24 Nov 2024 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement and digital documentation | – | Device: ISAR-M THYROcontinuous measurement and digital documentation with alarms and display off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Intended use of drains
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISAR-M THYROA diagnostic device for early detection of haemorrhage following thyroid surgery | Device | Measurement and digital documentation |
Primary outcome
Sensitivity and specificity
Time frame: within 48 hours following thyroid surgery
detection of clinically relevant haemorrhage compared to the gold standard of detection in routine clinical care using 15 mmHg as cut-off
Sensitivity and specificity
Time frame: within 48 hours following thyroid surgery
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
2 secondary outcomes
Specificity
Time frame: within 48 hours following thyroid surgery
Safety of the use of ISAR-M THYRO
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Thyroid
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
Sedentary Behavior, Acute Exercise
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus MA Albertsmeier, Dr. study chair
Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid, run by ISAR-M GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivia Fedunik-Brehm (+491735667761, olivia.fedunik-brehm@isar-m.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: within 48 hours following thyroid surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.