Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 6:36 AM
Study NCT ID:
NCT06195657
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Localization of Ground Glass Solitary Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of the procedure', 'timeFrame': 'Up to 4 hours', 'description': 'Percentage of hook wires remaining anchored during the surgical resection of suspect nodules'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Up to 4 hours', 'description': 'Rate of complication of the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'Objectives: The main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (VATS) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. In order to reduce the friction of the thread in the wall, the investigators modified the technique by first positioning a catheter in the chest wall and introducing the carrying needle through the catheter. The objective was to evaluate the success rate and complications of this technique.\n\nMaterial and Methods : the investigators retrospectively included all patients undergoing VATS resection of solitary lung nodules after localization using the sliding wire technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the university hospital of Nice, France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n\\- All patients who underwent VATS for pulmonary nodule resection in the thoracic surgery department of Nice University hospital after pre-operative hook-wire insertion using the sliding-wire technique\n\nExclusion criteria: None'}, 'identificationModule': {'nctId': 'NCT06195657', 'acronym': 'SLIDINGWIRE', 'briefTitle': 'Pre-operative Localization of Ground Glass Solitary Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Pre-video Assisted Thoracoscopy Surgery (VATS) Localization of Ground Glass Solitary Pulmonary Nodules: the Sliding Wire Technique', 'orgStudyIdInfo': {'id': '23Imagerie04'}}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Bernard Padovani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}