Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 12:06 AM
Study NCT ID:
NCT06693258
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Comparative, Monocentric Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the post-operative quality of life at D30 between the two groups', 'timeFrame': 'day 30', 'description': 'thyca-Qol'}], 'secondaryOutcomes': [{'measure': 'Total dysphagia score between the two groups', 'timeFrame': 'Day7, Day30 and 3 months', 'description': 'EAT-10 scale'}, {'measure': 'Quality of the scar between the two groups', 'timeFrame': 'day 30', 'description': 'Vancouver scale'}, {'measure': 'Assess the functional recovery of the vocal cords', 'timeFrame': 'day 7 and day 30', 'description': 'fibroscopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged over 20 years\n* Referred for a thyroidectomy (total or partial)\n* Absence of participation in another clinical study\n* Subject affiliated to a social security scheme or beneficiary of such a scheme\n* Accepts the completion of the various study questionnaires\n\nExclusion Criteria:\n\n* Patient under 20 years of age.\n* Patients who have undergone combined radical cervical lymph node dissection\n* Patient with a postoperative wound problem\n* Patient with an underlying systemic disease that may influence the wound healing process\n* Unable to undergo medical follow-up for the study.'}, 'identificationModule': {'nctId': 'NCT06693258', 'acronym': 'CARTO', 'briefTitle': 'Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Bizet'}, 'officialTitle': 'A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy', 'orgStudyIdInfo': {'id': '2024-A01697-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'thyroidectomy by robotic surgery via axillary approach', 'interventionNames': ['Procedure: thyroidectomy by robotic surgery via axillary approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'thyroidectomy by standard conventional surgery', 'interventionNames': ['Procedure: thyroidectomy by standard conventional surgery']}], 'interventions': [{'name': 'thyroidectomy by robotic surgery via axillary approach', 'type': 'PROCEDURE', 'description': 'thyroidectomy', 'armGroupLabels': ['Experimental group']}, {'name': 'thyroidectomy by standard conventional surgery', 'type': 'PROCEDURE', 'description': 'thyroidectomy by standard conventional surgery', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75116', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'bouchra benkessou, chef de projet', 'role': 'CONTACT', 'email': 'b.benkessou@hexagone-sante-paris.fr', 'phone': '07 64 48 60 16'}, {'name': 'Patrick AIDAN, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'clinique Bizet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Bizet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}