Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-02 @ 12:42 PM
Study NCT ID:
NCT03347903
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}], 'ancestors': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-18', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease', 'timeFrame': 'January 2014- May 2017', 'description': 'All patients that are referred to our center with symptoms of gastroesophageal reflux disease routinely undergo high-resolution manometry. We assess how many patients are diagnosed with Jackhammer esophagus'}], 'secondaryOutcomes': [{'measure': 'Symptom perception', 'timeFrame': 'January 2014- May 2017', 'description': 'We assess which symptoms are perceived by the patients diagnosed with Jackhammer esophagus. All data are observed during an interview at the high-resolution manometry'}, {'measure': 'Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus', 'timeFrame': 'Januar 2014- May 2017', 'description': 'All patients that are referred to our center are evaluated for gastroesophageal reflux disease. We assess the prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus diagnosed by ambulatory pH monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophagus', 'motility'], 'conditions': ['Esophageal Motility Disorders']}, 'referencesModule': {'references': [{'pmid': '29967357', 'type': 'DERIVED', 'citation': 'Kristo I, Schwameis K, Maschke S, Kainz A, Rieder E, Paireder M, Jomrich G, Schoppmann SF. Phenotypes of Jackhammer esophagus in patients with typical symptoms of gastroesophageal reflux disease responsive to proton pump inhibitors. Sci Rep. 2018 Jul 2;8(1):9949. doi: 10.1038/s41598-018-27756-9.'}]}, 'descriptionModule': {'briefSummary': 'Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy.\n\nThis trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.', 'detailedDescription': 'Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that are referred to our center undergo esophageal high-resolution manometry and ambulatory pH monitoring for screening of gastroesophageal reflux disease and motility disorders. We assess the data that are prospectively obtained. Patients do not have to undergo any interventions.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus\n\nExclusion Criteria:\n\n* patients not willing to participate data or undergo screening for gastroesophageal reflux disease'}, 'identificationModule': {'nctId': 'NCT03347903', 'briefTitle': 'Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': '1164/2017'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sebastian Schoppmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vice Chair of Department of General Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. univ.', 'investigatorFullName': 'Dr. Ivan Kristo', 'investigatorAffiliation': 'Medical University of Vienna'}}}}