Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-28 @ 8:53 PM
Study NCT ID:
NCT05044351
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2021-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Patients and related health care staff will be blinded for the allocated intervention until the day of surgery'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2021-09-05', 'studyFirstSubmitQcDate': '2021-09-05', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parathyroid gland identification rate', 'timeFrame': 'Will be assessed at the time of surgery'}], 'secondaryOutcomes': [{'measure': 'Rate of inadvertent parathyroid excision', 'timeFrame': 'Will be assessed one month following surgery'}, {'measure': 'Rate of autotransplantation', 'timeFrame': 'Will be assessed at the time of surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autofluorescence', 'Thyroidectomy', 'Autotransplantation']}, 'referencesModule': {'references': [{'pmid': '38573333', 'type': 'DERIVED', 'citation': 'Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075.'}]}, 'descriptionModule': {'briefSummary': 'Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.\n\nIn order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:\n\nAim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.', 'detailedDescription': 'Patients referred for hemithyroidectomy will be randomized to either:\n\n(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for thyroid lobectomy\n* Age \\> 18\n* Able to understand patient information\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Completion lobectomy\n* Need for accelerated surgery\n* Age \\< 18\n* Unable to understand patient information\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT05044351', 'briefTitle': 'Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital West Jutland'}, 'officialTitle': 'Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Autofluorescence2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(A): NIRAF-assisted surgery', 'description': 'Patients undergoing NIRAF-assisted hemithyroidectomy', 'interventionNames': ['Device: Fluobeam LX']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(B): Conventional surgery', 'description': 'Patients undergoing conventional hemithyroidectomy without NIRAF-assistance', 'interventionNames': ['Other: Conventional surgery without NIRAF assistance']}], 'interventions': [{'name': 'Fluobeam LX', 'type': 'DEVICE', 'description': 'See arm description', 'armGroupLabels': ['(A): NIRAF-assisted surgery']}, {'name': 'Conventional surgery without NIRAF assistance', 'type': 'OTHER', 'description': 'Patients undergoing conventional hemithyroidectomy without NIRAF-assistance', 'armGroupLabels': ['(B): Conventional surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Department of Otorhinolaryngology, Regional Hospital West Jutland', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital West Jutland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ali Abood', 'investigatorAffiliation': 'Regional Hospital West Jutland'}}}}