Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 4:36 PM
Study NCT ID:
NCT06240650
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2023-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability of a Modified Health-Dx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects.', 'timeFrame': 'day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals ages 18 - 75 inclusive\n* Subject is a suitable candidate for study participation in the opinion of the Investigator\n* Subject has been informed of the nature of the study and has provided written informed consent as approved by the WVU IRB\n\nExclusion Criteria:\n\n* Subjects with a history of any condition that may impact the GI tract\n* Subjects who are unable to swallow a 000 sized capsule\n* Subjects with an implanted medical device that has wireless data communication capability\n* Subjects planning to undergo an MRI within 30 days after the study\n* Subjects with a BMI \\> 40 (severe obesity)\n* Subjects who are pregnant or are nursing\n* Any subject deemed to be at risk of a gastrointestinal complication as evaluated by a gastroenterologist prior to study enrollment'}, 'identificationModule': {'nctId': 'NCT06240650', 'briefTitle': 'Tolerability of a Modified Health-Dx', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celero Systems, Inc.'}, 'officialTitle': 'Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx', 'orgStudyIdInfo': {'id': 'CEL-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'modified Health- Dx™ (mHDx) study capsule', 'interventionNames': ['Device: modified Health- Dx™ (mHDx) study capsule']}, {'type': 'OTHER', 'label': 'modified Health- Dx™ (mHDx) control capsule', 'interventionNames': ['Device: modified Health- Dx™ (mHDx) control capsule']}], 'interventions': [{'name': 'modified Health- Dx™ (mHDx) study capsule', 'type': 'DEVICE', 'description': "The Study mHDx capsule has a mechanism that allows the mHDx to remain resident in the stomach for no more than six (6) hours. After this residency period, the Study mHDx will disassemble and pass safely through the subject's gastrointestinal system.", 'armGroupLabels': ['modified Health- Dx™ (mHDx) study capsule']}, {'name': 'modified Health- Dx™ (mHDx) control capsule', 'type': 'DEVICE', 'description': "The Control mHDX capsule does not have a functional residency mechanism so it will disassemble once safely through the esophagus (within 10 minutes) and will then pass safely through the subject's gastrointestinal system.", 'armGroupLabels': ['modified Health- Dx™ (mHDx) control capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celero Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}