NCT04845867 A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product
| NCT ID | NCT04845867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ISAR-M GmbH |
| Condition | Thyroid |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,470 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2024-10-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,470 participants in total. It began in 2023-10-23 with a primary completion date of 2024-10-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Markus MA Albertsmeier, Dr.
STUDY CHAIR
Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,
Frequently Asked Questions
Who can join the NCT04845867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04845867 currently recruiting?
Yes, NCT04845867 is actively recruiting participants. Contact the research team at olivia.fedunik-brehm@isar-m.com for enrollment information.
Where is the NCT04845867 trial being conducted?
This trial is being conducted at Hausham, Germany.
Who is sponsoring the NCT04845867 clinical trial?
NCT04845867 is sponsored by ISAR-M GmbH. The principal investigator is Markus MA Albertsmeier, Dr. at Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,. The trial plans to enroll 1,470 participants.