Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 11:27 PM
Study NCT ID:
NCT04423003
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Interventions in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death in time of observation', 'timeFrame': '01.March 2020 to 5. May 2020', 'description': 'death in time of observation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Change; Endoscopy, COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a combined study including a descriptive part about the preparations for COVID-19 and the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who required endoscopic intervention.\n\nResults are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3. Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2 infection.', 'detailedDescription': 'This article is intended to provide an overview of the impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit (IEU, gastroenterological endoscopy, surgical endoscopy, and bronchoscopy) at the University Hospital Tübingen, a center for tertiary care in South-western Germany. First, preparations for COVID-19 pandemic with respect to the IEU are presented, and compared with those of other endoscopy units (7, 8). Additionally, the direct impact of SARS-CoV-2 on the staff of the IEU will be shown, together with a point-prevalence analysis of SARS-CoV-2 of the staff at the end of the SARS-CoV-2 wave in Tübingen. Finally, to our knowledge for the first time, we conducted a prospective single center analysis of the patients infected with SARS-CoV-2, which required a diagnostic or therapeutic endoscopic intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '10 patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with proven or suspected infections with SARS-CoV-2 infection, who required endoscopic interventions\n\nExclusion Criteria:\n\n* all other patients'}, 'identificationModule': {'nctId': 'NCT04423003', 'briefTitle': 'Endoscopic Interventions in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Impact of the COVID-19 Pandemic on an Interdisciplinary Endoscopy Unit in a German "Hotspot" Area: a Single Center Experience', 'orgStudyIdInfo': {'id': '242/2020BO2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic intervention', 'type': 'PROCEDURE', 'description': 'All endoscopic interventions in COVID-19 positive tested patients were included'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital of Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}