Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT06011369
Status:
UNKNOWN
Last Update Posted:
2023-09-06
First Post:
2023-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Usefulness of Fluorescence in Thiroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005453', 'term': 'Fluorescence'}], 'ancestors': [{'id': 'D049449', 'term': 'Luminescence'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PROSPECTIVE, CONTROLLED, RANDOMIZED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of surgery performed', 'timeFrame': 'Up to 12 months.', 'description': 'total thyroidectomy/hemithyroidectomy; lymphadenectomy'}, {'measure': 'Number of parathyroid glands identified before the use of AF (Autofluorescence)', 'timeFrame': 'Up to 12 months.', 'description': 'Gland count'}, {'measure': 'Number and location of parathyroid glands identified with the use of FA (Autofluorescence)', 'timeFrame': 'Up to 12 months.', 'description': 'Gland count'}, {'measure': 'Quantification of each parathyroid gland with AF(Autofluorescence)', 'timeFrame': 'Up to 12 months.', 'description': "(two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist"}, {'measure': 'Number of glands accidentally removed.', 'timeFrame': 'Up to 12 months.', 'description': 'Gland count'}, {'measure': 'Number of autotransplanted glands.', 'timeFrame': 'Up to 12 months.', 'description': 'Gland count'}, {'measure': 'Surgical time.', 'timeFrame': 'Up to 12 months.', 'description': 'Hours of surgery'}, {'measure': 'Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)', 'timeFrame': 'Up to 12 months.', 'description': 'Number of surgeries using autofluorescence'}, {'measure': 'Concentration of PTH and calcium corrected by albumin and/or ionic', 'timeFrame': '4, 24 Hours', 'description': 'Value in analytics'}, {'measure': 'Concentration of PTH and calcium corrected by albumin and/or ionic', 'timeFrame': '6,12 Months', 'description': 'Value in analytics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Surgery']}, 'descriptionModule': {'briefSummary': 'In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.\n\nFor this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total thyroidectomy with/without lymph node dissection\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Hemithyroidectomy\n* Reintervention of thyroid surgery'}, 'identificationModule': {'nctId': 'NCT06011369', 'acronym': 'ECA_SPAFLUO', 'briefTitle': 'Study of Usefulness of Fluorescence in Thiroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia'}, 'officialTitle': 'A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery', 'orgStudyIdInfo': {'id': 'IMIB-SPAFLUO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluorescence in thyroid surgery', 'description': 'Patients undergoing thyroid surgery with cervical fluorescence.', 'interventionNames': ['Procedure: Fluorescence in thyroid surgery']}, {'type': 'NO_INTERVENTION', 'label': 'No Fluorescence in thyroid surgery', 'description': 'patients undergoing thyroid surgery without cervical fluorescence.'}], 'interventions': [{'name': 'Fluorescence in thyroid surgery', 'type': 'PROCEDURE', 'description': 'Fluorescence in thyroid surgery', 'armGroupLabels': ['Fluorescence in thyroid surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Beatriz Febrero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Beatriz Febrero, MD', 'role': 'CONTACT', 'email': 'beatriz.febrero@um.es', 'phone': '968 36 95 00'}], 'overallOfficials': [{'name': 'Beatriz Febrero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCUVA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}