Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 5:50 AM
Study NCT ID:
NCT05696561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-14
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP change', 'timeFrame': 'Month6', 'description': 'proportion of treated eyes with \\> 20% change in unmedicated IOP'}], 'secondaryOutcomes': [{'measure': 'IOP', 'timeFrame': 'Months 6 and 12', 'description': 'Change in IOP'}, {'measure': 'IOP meds', 'timeFrame': 'Month 6 and 12', 'description': 'Change in number of IOP lowering medications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['POAG']}, 'descriptionModule': {'briefSummary': 'Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects qualifying for cataract surgery\n2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.\n\nExclusion Criteria:\n\n1\\. Patients who cannot be washed-out of IOP-lowering medications.'}, 'identificationModule': {'nctId': 'NCT05696561', 'briefTitle': 'Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'New World Medical, Inc.'}, 'officialTitle': 'A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery', 'orgStudyIdInfo': {'id': 'DF12-CL-22-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with a Canaloplasty Device', 'description': 'Canaloplasty Device', 'interventionNames': ['Device: Canaloplasty Device']}], 'interventions': [{'name': 'Canaloplasty Device', 'type': 'DEVICE', 'description': 'Canaloplasty', 'armGroupLabels': ['Treatment with a Canaloplasty Device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San José', 'country': 'Costa Rica', 'facility': 'Clinica 20/20', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Santa Rosa de Copán', 'country': 'Honduras', 'facility': 'Centro Oftalmologico Robles', 'geoPoint': {'lat': 14.77388, 'lon': -88.7756}}, {'city': 'Puebla City', 'country': 'Mexico', 'facility': 'Laser y Ultrasonido Ocular', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}], 'centralContacts': [{'name': 'Heather P Reynolds, MS', 'role': 'CONTACT', 'email': 'hreynolds@newworldmedical.com', 'phone': '8176881689'}], 'overallOfficials': [{'name': 'Mark Sun, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New World Medical, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New World Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}