Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 6:19 AM
Study NCT ID:
NCT01663493
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2012-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Methods to Biopsy Pancreas Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-11', 'studyFirstSubmitDate': '2012-08-09', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of passes', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreas Mass Diagnosis']}, 'descriptionModule': {'briefSummary': 'This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* pancreas mass\n\nExclusion Criteria:\n\n* coagulopathy\n* mass not approachable by endoscopic ultrasound biopsy'}, 'identificationModule': {'nctId': 'NCT01663493', 'briefTitle': 'Comparing Methods to Biopsy Pancreas Mass', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses', 'orgStudyIdInfo': {'id': '2012-P-000955/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fine needle aspiration needle', 'description': 'standard Beacon FNA needle', 'interventionNames': ['Procedure: FNB']}, {'type': 'OTHER', 'label': 'fine needle biopsy needle', 'description': 'SharkCore fine needle biopsy needle', 'interventionNames': ['Procedure: FNB']}], 'interventions': [{'name': 'FNB', 'type': 'PROCEDURE', 'armGroupLabels': ['Fine needle aspiration needle', 'fine needle biopsy needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Linda S Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Linda S. Lee', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}