Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-02-27 @ 5:09 PM
Study NCT ID:
NCT02194920
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2014-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample', 'timeFrame': 'up to 3 months', 'description': 'The primary outcome will be the assessment of reimplanted parathyroid function, evaluated by intact Parathormone (iPTH) measurement by separate blood samples (left and right arm) at 7 days, 1 month and 3 months after surgery. Ratio of 1.5 between the iPTH levels in the arm receiving graft and the opposite arm will be predictive of graft functionality'}]}, 'conditionsModule': {'conditions': ['Thyroid Goiter', 'Thyroid Carcinoma', 'Multinodular Goiter', 'Graves Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients receiving thyroid surgery with accidental removal or devascularization of normal parathyroid gland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affected by benign thyroid disease undergoing thyroidectomy'}, 'identificationModule': {'nctId': 'NCT02194920', 'briefTitle': 'Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Arathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function', 'orgStudyIdInfo': {'id': '06072011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parathyroid reimplantation', 'interventionNames': ['Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue']}], 'interventions': [{'name': 'Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue', 'type': 'PROCEDURE', 'armGroupLabels': ['Parathyroid reimplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04100', 'city': 'Latina', 'country': 'Italy', 'facility': 'General Surgery Unit, ICOT Hospital', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Giuseppe Cavallaro, MD PhD', 'investigatorFullName': 'Giuseppe Cavallaro', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}