Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT04938102
Status:
WITHDRAWN
Last Update Posted:
2024-10-21
First Post:
2021-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Administrative-not IRB approved', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Resolution', 'timeFrame': '12 weeks.', 'description': 'The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score \\< 3) post procedure in each group.'}], 'secondaryOutcomes': [{'measure': 'Percent change in symptom score', 'timeFrame': '12 weeks.', 'description': 'The secondary endpoint is the percent change in symptom score at 12 weeks in each group.'}, {'measure': 'Mean symptom scores', 'timeFrame': '12 weeks.', 'description': 'The secondary endpoint is the change in mean symptom score in each group at 12 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophagogastric Junction Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.', 'detailedDescription': "Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.\n\n1\\. Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with esophagogastric junction outflow obstruction by high resolution manometry\n\nExclusion Criteria:\n\n* previous upper gastrointestinal surgery\n* significant medical co-morbidities\n* eosinophilic esophagitis\n* severe reflux esophagitis (LA-classification C or D)\n* large hiatal hernia\n* patients experiencing significant weight loss suspicious for malignancy\n* Vulnerable populations such as cognitively or decisionally impaired individuals, children, pregnant women, prisoners, and students or employees of the University of Kansas Health System or Medical Center'}, 'identificationModule': {'nctId': 'NCT04938102', 'acronym': 'EndoFLIP', 'briefTitle': 'Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction', 'orgStudyIdInfo': {'id': 'STUDY00147450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Abnormal DI - Control', 'description': "Patients' whose distensibility index is measured \\<2.8 will receive no intervention."}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abnormal DI - Botox', 'description': "Patients' whose distensibility index is measured \\<2.8 will be injected with 100 units of botulinum toxin in the lower esophageal sphincter (25 units in each quadrant).", 'interventionNames': ['Drug: Botulinum Toxin Type A Injection [Botox]']}, {'type': 'NO_INTERVENTION', 'label': 'Normal DI - Control', 'description': "Patients' whose distensibility index is measured \\>2.8 will receive no intervention."}], 'interventions': [{'name': 'Botulinum Toxin Type A Injection [Botox]', 'type': 'DRUG', 'description': 'Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).', 'armGroupLabels': ['Abnormal DI - Botox']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Reza Hejazi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reza Hejazi', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}