Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-31 @ 2:21 AM
Study NCT ID:
NCT01257633
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2010-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2010-12-09', 'studyFirstSubmitQcDate': '2010-12-09', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Time to prepare the surgical setting (min)', 'timeFrame': '1 day'}, {'measure': 'Time necessary to dock the robot (min)', 'timeFrame': '1 day'}, {'measure': 'Total surgical time (console time) (min)', 'timeFrame': '1 day'}, {'measure': 'Intervention time taking into account cervical ganglions (min)', 'timeFrame': '1 day'}, {'measure': 'Was a tracheotomy necessary? yes/no', 'timeFrame': '1 day'}, {'measure': 'Presence / absence of bleeding complications', 'timeFrame': '1 day'}, {'measure': 'Was a conversion to an open procedure necessary? yes/no', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['da Vinci surgical robot', 'laryngeal cancer'], 'conditions': ['Laryngeal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '29032418', 'type': 'RESULT', 'citation': 'Lallemant B, Moriniere S, Ceruse P, Lebalch M, Aubry K, Hans S, Dolivet G, Malard O, Bonduelle Q, Vergez S. Transoral robotic surgery for squamous cell carcinomas of the posterior pharyngeal wall. Eur Arch Otorhinolaryngol. 2017 Dec;274(12):4211-4216. doi: 10.1007/s00405-017-4771-9. Epub 2017 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is aimed at all patients with early stage (T1 or T2) glottic and / or supraglottic squamous cell carcinoma of the larynx, whatever their status and cervical lymph nodes without distant metastases (M0) and for whom endoscopic surgical treatment with robotic assistance is indicated following a multidisciplinary meeting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject has signed consent\n* The subject must be a member or beneficiary of a health insurance plan\n* The patient is available for 12 months of follow-up\n* The subject has a cancer of the larynx:\n* classified T1 or T2 in the TNM\n* glottic localization and / or supraglottic regardless of node status\n* with or without a history of head and neck cancer\n* The subject does not have distant metastasis (M0)\n* A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01257633', 'briefTitle': 'Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance', 'orgStudyIdInfo': {'id': 'AOI/2010/BL-01'}, 'secondaryIdInfos': [{'id': '2010-A01190-39', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study population', 'description': 'Laryngeal cancer patients requiring surgical tumor resection.', 'interventionNames': ['Procedure: Transoral robot-assisted tumor resection using the da Vinci robot']}], 'interventions': [{'name': 'Transoral robot-assisted tumor resection using the da Vinci robot', 'type': 'PROCEDURE', 'description': 'Transoral robot-assisted tumor resection using the da Vinci robot', 'armGroupLabels': ['The study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHRU de Toulouse - Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Benjamin Lallemant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}