Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03598933
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cricopharyngeal Dysfunction in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deglutition Handicap Index', 'timeFrame': 'The period from January 1st, 2017 to December 31st, 2017 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper Esophageal Sphincter', 'botulinum toxin', 'Cricopharyngeal dysfunction', 'Cricopharyngeal botulinum toxin injection'], 'conditions': ['Upper Esophageal Sphincter']}, 'descriptionModule': {'briefSummary': 'The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman whose age older than 18 years\n* Dysphagia with solids and / or liquids\n* Dysfunction of primary or secondary Upper Esophageal Sphincter with indirect video-fibroscopy and / or video-fluoroscopy and / or high resolution pharyngo-oesophageal manometry\n* Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.\n* Subject who has consented to the use of his data from his medical file for the purpose of this research\n\nExclusion Criteria:\n\n* Myotomy in the first place\n* Refusal of the subject to participate in the study\n* Subject under the protection of justice\n* Subject under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03598933', 'briefTitle': 'Cricopharyngeal Dysfunction in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection', 'orgStudyIdInfo': {'id': '7053'}}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Schultz, MD, PhD', 'role': 'CONTACT', 'email': 'philippe.schultz@chru-strasbourg.fr', 'phone': '33 3 88 12 76 35'}, {'name': 'Philippe Schultz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sophie Gorostis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service ORL et chirurgie cervico-faciale', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Philippe Schultz, MD, PhD', 'role': 'CONTACT', 'email': 'philippe.schultz@chru-strasbourg.fr', 'phone': '33 3 88 12 76 35'}, {'name': 'Sophie Gorostis, MD', 'role': 'CONTACT', 'email': 'sophie.gorostis@chru-strasbourg.fr', 'phone': '33 3 88 12 76 35'}], 'overallOfficials': [{'name': 'Philippe Schultz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}