Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04845867
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1470}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity', 'timeFrame': 'within 48 hours following thyroid surgery', 'description': 'detection of clinically relevant haemorrhage compared to the gold standard of detection in routine clinical care using 15 mmHg as cut-off'}, {'measure': 'Sensitivity and specificity', 'timeFrame': 'within 48 hours following thyroid surgery', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': 'within 48 hours following thyroid surgery', 'description': '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'}, {'measure': 'Safety of the use of ISAR-M THYRO', 'timeFrame': '1 month', 'description': 'Safety of the use of ISAR-M THYRO by means of adverse events within 1 month following thyroid surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* 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.\n* Signed informed consent\n\nExclusion Criteria:\n\n\\- Intended use of drains'}, 'identificationModule': {'nctId': 'NCT04845867', 'acronym': 'HEDOS', 'briefTitle': 'A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'ISAR-M GmbH'}, 'officialTitle': 'Thyroid HEmorrhage DetectOr Study', 'orgStudyIdInfo': {'id': 'HEDOS-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Measurement and digital documentation', 'description': 'continuous measurement and digital documentation with alarms and display off', 'interventionNames': ['Device: ISAR-M THYRO']}], 'interventions': [{'name': 'ISAR-M THYRO', 'type': 'DEVICE', 'description': 'A diagnostic device for early detection of haemorrhage following thyroid surgery', 'armGroupLabels': ['Measurement and digital documentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83734', 'city': 'Hausham', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas TA von Ahnen, Dr.', 'role': 'CONTACT', 'email': 'thomas.ahnenvon@khagatharied.de', 'phone': '+49 802 6393 4352'}, {'name': 'Peter PB Busch, Dr.', 'role': 'CONTACT', 'email': 'peter.busch@khagatharied.de', 'phone': '+49 8026 393 4428'}], 'facility': 'Krankenhaus Agatharied', 'geoPoint': {'lat': 47.7466, 'lon': 11.84069}}], 'centralContacts': [{'name': 'Olivia Fedunik-Brehm', 'role': 'CONTACT', 'email': 'olivia.fedunik-brehm@isar-m.com', 'phone': '+491735667761'}, {'name': 'Sabrina Koschel', 'role': 'CONTACT', 'email': 'hedos@cri-muc.eu', 'phone': '+49 89 9901649975'}], 'overallOfficials': [{'name': 'Markus MA Albertsmeier, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ISAR-M GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CRI-The Clinical Research Institute GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}