Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-03-01 @ 8:29 PM
Study NCT ID:
NCT02366858
Status:
WITHDRAWN
Last Update Posted:
2017-02-14
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI decision was made to discontinue the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '22 gauge needle', 'timeFrame': '72 hours', 'description': 'Compare the quality of core tissue specimens obtained between a 19G and 22G needle by evaluating the ability to perform molecular marker studies or immunohistochemistry studies between samples obtained.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['19 gauge', '22 gauge', 'core tissue'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.', 'detailedDescription': 'Inclusion Criteria\n\n1. Age under 19 years\n2. Pregnant women will be excluded. This will be confirmed by self-report\n\nExclusion Criteria\n\n1. Age under 19 years\n2. Pregnant women will be excluded. This will be confirmed by self-report'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)\n\nExclusion Criteria:\n\n* Age under 19 years\n* Pregnant women will be excluded. This will be confirmed by self-report'}, 'identificationModule': {'nctId': 'NCT02366858', 'briefTitle': 'Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures', 'orgStudyIdInfo': {'id': '510467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '19 gauge', 'description': 'Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle.', 'interventionNames': ['Procedure: 19 gauge']}, {'type': 'ACTIVE_COMPARATOR', 'label': '22 gauge', 'description': 'Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle.', 'interventionNames': ['Procedure: 19 gauge', 'Procedure: 22 gauge']}], 'interventions': [{'name': '19 gauge', 'type': 'PROCEDURE', 'description': 'Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle', 'armGroupLabels': ['19 gauge', '22 gauge']}, {'name': '22 gauge', 'type': 'PROCEDURE', 'description': 'Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle', 'armGroupLabels': ['22 gauge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Shyam Varadarajulu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}