Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-04 @ 3:07 PM
Study NCT ID:
NCT05396703
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOETVA Feasibility and Complications - Single Center First Experience
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': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications initial', 'timeFrame': 'Immediately postoperative (during hospitalization)', 'description': 'Complications after performed surgery'}, {'measure': 'Complications before follow-up', 'timeFrame': 'If premature presentation occurs (admission after discharge and before follow-up consultation at 1 month after surgery)', 'description': 'Complications after performed surgery'}, {'measure': 'Complications before follow-up', 'timeFrame': 'Data at first follow-up visit will be reported. First follow-up visit will be at (average) 1 month after discharge.', 'description': 'Complications after performed surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TOETVA', 'NOTES', 'Surgery', 'Endocrine', 'Thyroid', 'Case Series'], 'conditions': ['Thyroid Gland Disease', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '38748236', 'type': 'DERIVED', 'citation': 'Kinet S, van Weezelenburg MAS, Pijnenburg A, Stoot JHMB, van Bastelaar J. Feasibility and complications after transoral endoscopic thyroidectomy via vestibular approach (TOETVA) - a single-center first experience case series. Langenbecks Arch Surg. 2024 May 15;409(1):158. doi: 10.1007/s00423-024-03347-3.'}]}, 'descriptionModule': {'briefSummary': "All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach at the investigators' center.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center\n\nExclusion Criteria:\n\n* Patients who did not undergo (or will not undergo) a TOETVA at the investigators' center"}, 'identificationModule': {'nctId': 'NCT05396703', 'briefTitle': 'TOETVA Feasibility and Complications - Single Center First Experience', 'organization': {'class': 'OTHER', 'fullName': 'Zuyderland Medisch Centrum'}, 'officialTitle': 'Feasibility and Complications After Transoral Endoscopic Thyroidectomy Via Vestibular Approach (TOETVA) - a Single-Center First Experience Case Series and Systematic Review', 'orgStudyIdInfo': {'id': 'BWO Z2021024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TOETVA', 'description': "All patients who underwent a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center.", 'interventionNames': ['Procedure: TOETVA']}], 'interventions': [{'name': 'TOETVA', 'type': 'PROCEDURE', 'description': 'Completed procedure.', 'armGroupLabels': ['TOETVA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6419 PC', 'city': 'Heerlen', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Zuyderland MC', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}], 'overallOfficials': [{'name': 'Sam Kinet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zuyderland MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymised patient sex, age, extent of resection, preoperative TSH values, TI-RADS classification, Bethesda classification, malignancy of lesion, and complications after surgery will be provided within the final manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zuyderland Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}