Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-29 @ 6:31 AM
Study NCT ID:
NCT02931461
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2016-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Procore Needle® for Diagnosis of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of histological diagnoses for each needle', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['endobronchial transbronchial needle aspiration lung cancer procore'], 'conditions': ['Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore']}, 'descriptionModule': {'briefSummary': 'The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mediastinal lymphadenopathy \\>10 millimeters\n* lung cancer suspected\n\nExclusion Criteria:\n\n* coagulopathy contraindication for midazolam contraindication for bronchoscopy'}, 'identificationModule': {'nctId': 'NCT02931461', 'briefTitle': 'Interest of Procore Needle® for Diagnosis of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'PR-EBUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'needle Procore ®', 'interventionNames': ['Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'needle Cook®', 'interventionNames': ['Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration']}], 'interventions': [{'name': 'Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration', 'type': 'PROCEDURE', 'armGroupLabels': ['needle Cook®', 'needle Procore ®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}