Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT05276557
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-06', 'mcpReleaseN': 4, 'releaseDate': '2024-12-12'}], 'estimatedResultsFirstSubmitDate': '2024-12-12'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with recorded adverse events', 'timeFrame': '24 hours', 'description': 'Number of participants with recorded adverse events after performing urea breath test'}], 'secondaryOutcomes': [{'measure': 'Percentage of Agreement', 'timeFrame': '7 days', 'description': 'Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Helicobacter Pylori', 'Safety', 'Efficacy']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.\n\nCenters will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.\n\nTreating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.\n\nTotal duration of study is anticipated to be approximately 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 3-17 at the time of visit\n* Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form\n* Naive to H. pylori treatment in the past 4 weeks\n\nExclusion Criteria:\n\n* Pregnant and/or lactating women\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data\n* Participation in other interventional trials\n* Allergy to test substrates\n* Antibiotics taken within 4 weeks of the testing\n* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food\n* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group'}, 'identificationModule': {'nctId': 'NCT05276557', 'briefTitle': 'PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ARJ Medical, Inc.'}, 'officialTitle': 'PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study', 'orgStudyIdInfo': {'id': 'ARJ-2022-PED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indication for H. pylori testing', 'description': 'Walk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison.', 'interventionNames': ['Combination Product: PyloPlus Urea Breath Test System', 'Diagnostic Test: Stool Antigen Test']}], 'interventions': [{'name': 'PyloPlus Urea Breath Test System', 'type': 'COMBINATION_PRODUCT', 'description': 'System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.', 'armGroupLabels': ['Indication for H. pylori testing']}, {'name': 'Stool Antigen Test', 'type': 'DIAGNOSTIC_TEST', 'description': "An antigen test performed via a laboratory to test patients' stool for H. pylori", 'armGroupLabels': ['Indication for H. pylori testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fermin Nieto', 'role': 'CONTACT', 'phone': '305-870-5999'}, {'name': 'Inosvani Barraso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dolphin Medical Research', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yazandra Parrimon, RN', 'role': 'CONTACT'}, {'name': 'Jeffrey Bornstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando Health, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arthur Imai', 'role': 'CONTACT', 'phone': '915-519-5297'}, {'name': 'Miguel Gutierrez', 'role': 'CONTACT', 'phone': '915-706-9902'}, {'name': 'Aldo Maspons, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harmony United Research', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'centralContacts': [{'name': 'Clinical Trial Manager', 'role': 'CONTACT', 'email': 'info@gulfcoastscientific.com', 'phone': '877-855-4100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARJ Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}