Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 6:07 AM
Study NCT ID:
NCT07156357
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surface EMG Testing on Swallowing in EoE Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004576', 'term': 'Electromyography'}], 'ancestors': [{'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009213', 'term': 'Myography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preparatory phase time', 'timeFrame': 'Through study completion an average of 2 days', 'description': 'Comparison of preparatory phase between cohorts'}], 'secondaryOutcomes': [{'measure': 'Time difference in swallow initiation', 'timeFrame': 'Through study completion an average of 2 days', 'description': 'Time difference in swallow initiation between fiberoptic endoscopic evaluation of swallowing (FEES) vs sEMG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis (EoE)']}, 'descriptionModule': {'briefSummary': 'Evaluating swallowing food with surface electromyography (EMG) machine in patients with Eosinophilic Esophagitis', 'detailedDescription': 'Evaluating surface electromyography (sEMG) assessment of swallowing and bolus preparation in patients with Eosinophilic Esophagitis (EoE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit patients with EoE seen in the esophageal clinic. Controls will be recruited by monitoring for patients that present for video swallow with speech language pathology and have a normal video swallow.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Controls\n\n * Normal video swallow or score of 0 for dysphagia on ESSAI questionnaire\n * absence of dysphagia\n * age \\>18 EoE participants\n * Documentation of EoE diagnosis by histologic criteria,\n * \\>15 eos/hpf on most recent esophageal biopsy\n * age \\>18\n\nExclusion Criteria:\n\n* Abnormal baseline video swallow\n* lack of MSK coordination to eat test meal\n* underlying neuromuscular disorder.'}, 'identificationModule': {'nctId': 'NCT07156357', 'acronym': 'sEMG', 'briefTitle': 'Surface EMG Testing on Swallowing in EoE Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'sEMG Assessment of Swallowing and Bolus Preparation', 'orgStudyIdInfo': {'id': '24-009832'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'Subjects who can swallow normally', 'interventionNames': ['Diagnostic Test: Surface Electromyography', 'Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing']}, {'label': 'Eosinophilic Esophagitis', 'description': 'Subjects with Eosinophilic Esophagitis', 'interventionNames': ['Diagnostic Test: Surface Electromyography', 'Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing']}], 'interventions': [{'name': 'Surface Electromyography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tests performed to evaluate swallowing function', 'armGroupLabels': ['Controls', 'Eosinophilic Esophagitis']}, {'name': 'Fiberoptic Endoscopic Evaluation of Swallowing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of swallowing function', 'armGroupLabels': ['Controls', 'Eosinophilic Esophagitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mariah Robran, CCRP', 'role': 'CONTACT', 'email': 'robran.mariah@mayo.edu', 'phone': '507-266-3595'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Ryan Alexander, MD', 'role': 'CONTACT', 'email': 'alexander.ryan2@mayo.edu', 'phone': '507-284-4824'}, {'name': 'Mariah Robran, CCRP', 'role': 'CONTACT', 'email': 'robran.mariah@mayo.edu', 'phone': '507-266-3595'}], 'overallOfficials': [{'name': 'Karthik Ravi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karthik Ravi, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}