Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-01-24 @ 7:29 PM
Study NCT ID:
NCT01858220
Status:
UNKNOWN
Last Update Posted:
2014-02-25
First Post:
2013-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IS There a Correlation Between Sypmtoms of Gastroparesis and the Duration of Video Caspule Retention in the Stomach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-12-18', 'releaseDate': '2015-11-16'}], 'estimatedResultsFirstSubmitDate': '2015-11-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2013-05-12', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of capsule retention in the stomach', 'timeFrame': 'End of capsule examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroparesis', 'Small bowel video capsule', 'gastric retention'], 'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': "Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim of the study is to determine the correlation between gasytoparesis symptoms to duration of capsule retention in the stomach"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient undergoing small bowel video capsule examination for any indication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Undergoing video capsule endoscopy for any indication\n\nExclusion Criteria:\n\n-Endoscopic intraduodenal insertion of the capsule -'}, 'identificationModule': {'nctId': 'NCT01858220', 'briefTitle': 'IS There a Correlation Between Sypmtoms of Gastroparesis and the Duration of Video Caspule Retention in the Stomach', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Open Prospective Single Center Study for the Determination of Correlation Between Video Capsule Period of Retention in the Stomach and Symptoms of Gastroparesis', 'orgStudyIdInfo': {'id': 'Sheba-9180-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Video capsule examinee', 'description': 'Every subject having capsule endoscopy for any indication'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Dan Carter, MD', 'role': 'CONTACT', 'email': 'carterd@zahav.net.il', 'phone': '972-3-5302197'}, {'name': 'Dan Carter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eytan Bardan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Dan Carter, MD', 'role': 'CONTACT', 'email': 'carterd@zahav.net.il', 'phone': '972-3-5302197'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior GI Consult', 'investigatorFullName': 'Dr. Dan Carter, Gastroenterologist', 'investigatorAffiliation': 'Sheba Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-11-16', 'type': 'RELEASE'}, {'date': '2015-12-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Dan Carter, Gastroenterologist, Senior GI Consult, Sheba Medical Center'}}}}