Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:47 AM
Study NCT ID:
NCT04969406
Status:
TERMINATED
Last Update Posted:
2022-06-10
First Post:
2021-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Trial of the Intelon BOSS(TM) System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Enrollment Difficulty', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility', 'timeFrame': 'Evaluation Visit (within 30 days of the Screening Visit)', 'description': 'A random effect model will be used to assess variation due to device/operator configuration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cornea', 'Lens Diseases']}, 'descriptionModule': {'briefSummary': 'A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 years or older\n2. Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule\n3. Signed Written Informed Consent\n\nExclusion Criteria:\n\n1. No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images\n2. Presence of corneal opacity\n3. Presence of cortical cataracts visible in an undilated pupil\n4. Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease)."}, 'identificationModule': {'nctId': 'NCT04969406', 'briefTitle': 'A Prospective Trial of the Intelon BOSS(TM) System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intelon Optics, Inc'}, 'officialTitle': 'A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System', 'orgStudyIdInfo': {'id': 'P21-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imaging by BOSS System', 'description': 'Imaging by the BOSS System', 'interventionNames': ['Other: Brillouin Spectroscopy via BOSS System']}], 'interventions': [{'name': 'Brillouin Spectroscopy via BOSS System', 'type': 'OTHER', 'description': 'Biomechanical Imaging of the Cornea and Lens', 'armGroupLabels': ['Imaging by BOSS System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision plc', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intelon Optics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}