Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 12:50 PM
Study NCT ID:
NCT00868504
Status:
UNKNOWN
Last Update Posted:
2009-09-30
First Post:
2009-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Temperatures of Tissues During Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-29', 'studyFirstSubmitDate': '2009-03-24', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of temperature between tumors and adjacent tissues', 'timeFrame': 'immediate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GI tract', 'Tumors', 'Temperatures'], 'conditions': ['Carcinoma, Undifferentiated']}, 'referencesModule': {'references': [{'pmid': '12515579', 'type': 'BACKGROUND', 'citation': 'Stefanadis C, Chrysohoou C, Panagiotakos DB, Passalidou E, Katsi V, Polychronopoulos V, Toutouzas PK. Temperature differences are associated with malignancy on lung lesions: a clinical study. BMC Cancer. 2003 Jan 6;3:1. doi: 10.1186/1471-2407-3-1. Epub 2003 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'Previous studies have indicated that tumors are warmer than the surrounding tissues. We want to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures. This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo endoscopy or colonoscopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consenting adults\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00868504', 'briefTitle': 'Measuring Temperatures of Tissues During Endoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Measuring Temperatures of Tumors and Normal Tissues in the GI Tract, Using a Thermocouple Sheathed in a Catheter, in the Work Canal of an Endoscope', 'orgStudyIdInfo': {'id': 'SHEBA-09-6887-AO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'examined by endoscopy', 'description': 'Patients, examined by endoscopy, being screened for GI tract tumors', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['examined by endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arie Orenstein, Prof.', 'role': 'CONTACT', 'email': 'gidi.arbel@sheba.health.gov.il', 'phone': '+97234303114'}, {'name': 'Gidi Arbel, Dr.', 'role': 'CONTACT', 'email': 'gidi.arbel@sheba.health.gov.il', 'phone': '+972544838960'}, {'name': 'Arie Orenstein, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Arie Orenstein, Prof.', 'role': 'CONTACT', 'email': 'gidi.arbel@sheba.health.gov.il', 'phone': '+97235303114'}], 'overallOfficials': [{'name': 'Arie Orenstein, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Prof. Arie Orenstein , Director Advanced Technologies Center', 'oldOrganization': 'Sheba Medical Center'}}}}