Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT06742034
Status:
COMPLETED
Last Update Posted:
2024-12-19
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliable and validated European Portuguese version of the VASES', 'timeFrame': 'patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology', 'description': 'Visual Analysis of Swallowing Efficiency and Safety (VASES) is a standardized approach for rating pharyngeal residue, penetration, and aspiration during FEES. It establishes clearly defined anatomic and temporal boundaries within which to rate functional swallowing outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dysphagia', 'Instrumental Assessment', 'Swallowing Disorders', 'Fiberoptic Endoscopic Evaluation of Swallow'], 'conditions': ['Deglutition Disorders', 'Deglutition']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who underwent FEES at the ULSEDV and met the study's inclusion and exclusion criteria.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient's FEES recording that allowed good visualization of the pharynx and larynx;\n* FEES recording from patients after head and neck surgery who had structural alterations but still did not interfere with a clear visualization of the residues.\n* Patient's tracheostomized or under enteral nutrition.\n\nExclusion Criteria:\n\n* Under 18 years of age"}, 'identificationModule': {'nctId': 'NCT06742034', 'acronym': 'VASES', 'briefTitle': 'Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar de Entre o Douro e Vouga'}, 'officialTitle': 'Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese', 'orgStudyIdInfo': {'id': '242023'}}, 'contactsLocationsModule': {'locations': [{'zip': '4520-211', 'city': 'Santa Maria da Feira', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Entre Douro e Vouga', 'geoPoint': {'lat': 40.92726, 'lon': -8.54839}}], 'overallOfficials': [{'name': 'Daniela Filipa Brás Ferreira, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidade Local de Saúde de Entre Douro e Vouga'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar de Entre o Douro e Vouga', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aveiro University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Speech and Language Pathologist', 'investigatorFullName': 'Daniela Ferreira', 'investigatorAffiliation': 'Centro Hospitalar de Entre o Douro e Vouga'}}}}