Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-28 @ 4:42 AM
Study NCT ID:
NCT04502732
Status:
TERMINATED
Last Update Posted:
2023-11-02
First Post:
2020-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to recruit sufficient participants form parent study following protocol expansion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2020-08-04', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of T1/2', 'timeFrame': 'Baseline, 2 months, 6 months', 'description': 'The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an EGRWL procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those eligible from relevant sub-studies.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be 22-65 years of age at time of enrollment\n* Subjects must already be consented to 17-007934 or 19-001254\n* Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.\n* If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline\n* Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits\n\nExclusion Criteria:\n\n* Persons presently or soon to be incarcerated\n* Females who are pregnant or suspect they may be pregnant\n* Persons with nicotine and/or alcohol dependence\n* Patients with cognitive impairment that limits their ability to make autonomous decisions\n* Known allergies or sensitivities to study materials (eggs and spirulina)\n* Assessed, by the physician or delegate, that enrollment would not be appropriate"}, 'identificationModule': {'nctId': 'NCT04502732', 'briefTitle': 'Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Direct Comparison of Short- And Long-Term Gastric Emptying By Nuclear Scintigraphy and Gastric Emptying Breath Test in Subjects Undergoing Endoscopic Gastric Remodeling For Weight Loss', 'orgStudyIdInfo': {'id': '20-002882'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'NSSM and GEBT', 'interventionNames': ['Other: NSSM and GEBT']}], 'interventions': [{'name': 'NSSM and GEBT', 'type': 'OTHER', 'description': 'The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Barham Abu Dayyeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barham K. Abu Dayyeh, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}