Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 1:45 PM
Study NCT ID:
NCT04772261
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GEBT Lot-to-Lot and Biological Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-30', 'mcpReleaseN': 3, 'releaseDate': '2024-10-09'}], 'estimatedResultsFirstSubmitDate': '2024-10-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-01', 'size': 2706945, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-23T13:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lot to Lot Variability', 'timeFrame': 'up to 3 months', 'description': 'Participant kPCD values at each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be plotted to compare in vivo results across each lot of material'}, {'measure': 'Lot to Lot Variability', 'timeFrame': 'up to 3 months', 'description': 'Pooled kPCD and standard deviations for each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be calculated and compared for the lot-to-lot comparisons'}, {'measure': 'Lot to Lot Variability', 'timeFrame': 'up to 3 months', 'description': 'Each set of pooled 13C-Spirulina test meal lot kPCD values will be calculated using a t-test or ANOVA to determine statistical equivalence'}, {'measure': 'Biological Variability', 'timeFrame': 'Up to 3 months', 'description': 'Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other'}, {'measure': 'Biological Variability', 'timeFrame': 'Up to 3 months', 'description': "Pooled, within subject standard deviations of duplicate measurements of kPCD values at each measured timepoint from the same lot of 13C-Spirulina GEBT test meal will be calculated for biological variation using Bartlett's test for homogeneity of variances"}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gastroenterology', 'Gastric emptying breath test'], 'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.', 'detailedDescription': 'In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18-85 years old at time of signing the informed consent form\n* Ability to eat test meal and provide breath samples\n\nExclusion Criteria:\n\n* History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.\n* History of abdominal surgery except appendectomy\n* Use of any medications that may alter gastric motility within two days of the study\n* Use of narcotics or anticholinergics within two days of the study\n* Females on hormone replacement therapy other than birth control medications\n* Pregnancy\n* Intolerance or allergy to any component of GEBT test meal\n* History of neurologic or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT04772261', 'briefTitle': 'GEBT Lot-to-Lot and Biological Variability', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cairn Diagnostics'}, 'officialTitle': '13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study', 'orgStudyIdInfo': {'id': 'PRO-CD-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lot-to-Lot Variability', 'description': 'Participants will be administered up to six different 13C-Spirulina test meal lots', 'interventionNames': ['Diagnostic Test: 13C-Spirulina GEBT']}, {'type': 'EXPERIMENTAL', 'label': 'Biological Variability', 'description': 'Participants will be administered the same 13C-Spirulina test meal lot on two different occasions', 'interventionNames': ['Diagnostic Test: 13C-Spirulina GEBT']}], 'interventions': [{'name': '13C-Spirulina GEBT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Various lots of 13C-Spirulina GEBT test meals', 'armGroupLabels': ['Biological Variability', 'Lot-to-Lot Variability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Cairn Diagnostics', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}], 'overallOfficials': [{'name': 'Alex Ryder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairn Diagnostics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairn Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}