Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-26 @ 11:01 PM
Study NCT ID:
NCT05452603
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness of Wireless pH Monitoring in GERD Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GERD Proportion', 'timeFrame': 'june 2021-june 2023', 'description': 'estimate the proportion of GERD measured by wireless pH monitoring capsule in patients in the gray area'}, {'measure': 'Therapeutic response', 'timeFrame': 'june 2021-june 2023', 'description': 'To compare the GERDq scale before and after treatment with proton pump inhibitors.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['gastroesophageal reflux disease', 'gray area', 'wireless pH monitoring'], 'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area.\n\nThe objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.', 'detailedDescription': 'Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.\n\nA 96-hour off IBP wireless pH monitoring capsule will be performed. The worst day, the average of the 4 days and the presence of 2 or more days with AET\\>6% and the 4 days with AET\\<4% will be recorded.\n\nPatients will be categorized into GERD, reflux hypersensitivity, and functional heartburn. A treatment will be established based on these categories and the GERDq will be measured at 8 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 18 years of age, with symptoms of Gastroesophageal Reflux, who have undergone a 24-hour impedance pH study without Proton Pump Inhibitors (PPIs), whose AET is between 4 and 6% will be included consecutively. .', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 18 years of age, with symptoms of gastroesophageal reflux, who have undergone a 24-hour impedance pH study without proton pump inhibitors (PPIs), whose AET is between 4 and 6% will be included consecutively. .\n\nExclusion Criteria:\n\n* Patients with severe comorbidities: Liver cirrhosis, oncological disease, autoimmune diseases, cognitive impairment, psychiatric diseases, bleeding diathesis or anticoagulation\n* Pregnant women\n* Patients with severe esophagitis, esophageal varices, esophageal strictures, Barrett's esophagus, anti-reflux surgery\n* Patients with history of pacemaker or defibrillator, since they can interfere with the signal.\n* Patients with nickel allergy\n* Patients that refuses to sign the informed consent."}, 'identificationModule': {'nctId': 'NCT05452603', 'briefTitle': 'Usefulness of Wireless pH Monitoring in GERD Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas José de San Martín'}, 'officialTitle': 'Usefulness of Wireless pH Monitoring in the Diagnosis of Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': '27251302710'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.', 'interventionNames': ['Device: 96-hour off IBP wireless pH monitoring capsule']}], 'interventions': [{'name': '96-hour off IBP wireless pH monitoring capsule', 'type': 'DEVICE', 'description': 'The endoscopic pH measurement capsule will be placed 6cm above the squamocolumnar junction, determined endoscopically, in the sedated patient. Then the plot will be read.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1622', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Clinicas Jose de San Martin. Buenos Aires University', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas José de San Martín', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maria Marta Piskorz', 'investigatorAffiliation': 'Hospital de Clinicas José de San Martín'}}}}