Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT02822456
Status:
UNKNOWN
Last Update Posted:
2019-12-03
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of EORTC QLQ - H&N35 index', 'timeFrame': '1 month after start of tube feeding', 'description': 'Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': 'after 1st session (3days) and after 1 month, and after 3 months', 'description': 'whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint'}, {'measure': 'change Mid-arm circumference', 'timeFrame': 'before VFSS and 1 month and 3 months after start of tube feeding'}, {'measure': 'change of Serum albumin', 'timeFrame': 'before VFSS and 1 month and 3 months after start of tube feeding'}, {'measure': 'change of MRS index', 'timeFrame': 'before VFSS and 1 month and 3 months after start of tube feeding'}, {'measure': 'change of success rate (rate of elimination)', 'timeFrame': 'after 1st session (3days), after 1 month, and after 3 months'}, {'measure': 'change of EORTC QLQ - H&N35 index', 'timeFrame': 'after 1st session (3days) and after 3 months', 'description': 'Measurement at leave hospital or start oral feeding can be another endpoint, Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dysphagia', 'intermittent tube', 'individual 3D printed guiding tube'], 'conditions': ['Dysphagia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the clinical effectiveness of IOE tube using individually customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when unconscious patients have no choice but tube feeding.', 'detailedDescription': 'According to standard Guideine of videofluoroscopic swallow study(VFSS), Patients referred to dysphagia(swallowing dysfunction)who were required to tube feeding and medically stable of vital sign, and agreed to participate. Participants with swallowing dysfunction who were classified into three groups (nasogastric tube, traditional intermittent (IOE) tube, individual 3D printed guiding tube) according to VFSS.\n\nBoth traditional IOE tube and individual 3D printed guiding tube groups will receive training about procedure prior to the first feeding. All participants will be evaluated with satisfaction for tube feeding (EORTC QLQ-H\\&N35) in 3 days from the start day of the tube feeding. On the day of oral feeding, participants will be evaluated with the questionnaires and clinical examination. If the participant is discharged in a state maintain the tube feeding, investigated further length stay at leaving the hospital. On the 1 month, 3 month from tube feeding, the investigators will follow-up and measure the questionnaires and clinical examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dysphagia patients to check in VFSS (videofluoroscopic swallow study)\n* Patients participating in the study agreement\n* Oral feeding is not possible (Need tube feeding)\n\nExclusion Criteria:\n\n* Patient to reject the participation\n* Crico-pharyngeal incoordination\n* Impaired esophageal peristalsis\n* Impaired GI tract\n* Observed esophageal reflux'}, 'identificationModule': {'nctId': 'NCT02822456', 'briefTitle': 'Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority', 'orgStudyIdInfo': {'id': 'chhwang5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual 3D-printed guided tube', 'description': 'IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat', 'interventionNames': ['Procedure: VFSS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional IOE tube', 'description': 'classic IOE tube feeding using nelaton tube only whenever they eat', 'interventionNames': ['Procedure: VFSS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nasogastric tube', 'description': 'nasogastric tube feeding using levin tube always', 'interventionNames': ['Procedure: VFSS']}], 'interventions': [{'name': 'VFSS', 'type': 'PROCEDURE', 'description': 'VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube', 'armGroupLabels': ['Individual 3D-printed guided tube', 'nasogastric tube', 'traditional IOE tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '682-714', 'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang Ho Hwang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chhwang1220ciba@gmail.com', 'phone': '+82-52-250-7210'}, {'name': 'Chang Ho Hwang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'centralContacts': [{'name': 'Chang Ho Hwang', 'role': 'CONTACT', 'email': 'chhwang1220ciba@gmail.com', 'phone': '+82-52-250-8898'}], 'overallOfficials': [{'name': 'Chang Ho Hwang, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chang Ho Hwang', 'investigatorAffiliation': 'Ulsan University Hospital'}}}}