Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 8:29 PM
Study NCT ID:
NCT05999006
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2023-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of the ELIOS System in POAG Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2023-08-11', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications', 'timeFrame': '12 Months', 'description': 'Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications'}, {'measure': 'Mean Change in DIOP from baseline on the same or fewer medications', 'timeFrame': '12 Months', 'description': 'Mean Change in DIOP from baseline on the same or fewer medications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma, Primary Open Angle']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of mild to moderate POAG\n* Medicated IOP of \\<=24 mmHg\n* Shaffer angle grade of III or IV\n* CD ratio \\<=0.8\n* At least 45 years old\n\nExclusion Criteria:\n\n* Closed-angle and secondary glaucomas\n* Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery\n* Cannot undergo medication washout in the study eye\n* Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control'}, 'identificationModule': {'nctId': 'NCT05999006', 'briefTitle': 'Safety and Feasibility of the ELIOS System in POAG Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elios Vision, Inc.'}, 'officialTitle': 'A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure', 'orgStudyIdInfo': {'id': 'EP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ELIOS Procedure', 'description': 'ELIOS Procedure', 'interventionNames': ['Device: ELIOS Procedure']}], 'interventions': [{'name': 'ELIOS Procedure', 'type': 'DEVICE', 'description': 'Treatment with the ELIOS System', 'armGroupLabels': ['ELIOS Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elios Vision Clinical Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elios Vision Clinical Site', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elios Vision Clinical Site', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elios Vision Clinical Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elios Vision Clinical Site', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}], 'centralContacts': [{'name': 'Rupali Nangia', 'role': 'CONTACT', 'email': 'rupali@eliosvision.com', 'phone': '714-227-6151'}], 'overallOfficials': [{'name': 'Iqbal (Ike) Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prism Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elios Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}