Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-25 @ 6:05 PM
Study NCT ID:
NCT07235592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Primary Safety Outcome Incidence of all device- and/or procedure-related adverse events', 'timeFrame': 'Screening to 12 months', 'description': 'This is a primary safety outcome for Incidence of all device- and/or procedure-related adverse events during the study'}], 'primaryOutcomes': [{'measure': 'Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure', 'timeFrame': 'Screening to 12 months', 'description': 'This is a primary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to \\<21 mmHg intraocular pressure from screening to 12 months'}], 'secondaryOutcomes': [{'measure': 'Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure', 'timeFrame': 'At 12 months', 'description': 'This is a secondary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to \\<18 mmHg intraocular pressure at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POAG'], 'conditions': ['Primary Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.', 'detailedDescription': "This is a prospective, multicentric, single arm post market clinical follow-up study to collect safety and performance data on the CE Marked PRESERFLO™ MicroShunt XI device in patients with primary open angle glaucoma. The PRESERFLO™MicroShunt XI employs a tube to create a conduit for the flow of aqueous humor from the anterior chamber of the eye to a bleb formed under the conjunctiva and Tenon's capsule; the front/ proximal end of the tube extends into the anterior chamber while the back/ distal end terminates in the bleb. The PRESERFLO™MicroShunt XI reduces IOP by physically shunting aqueous humor from the high pressure anterior chamber to the lower pressure bleb. The intended users of the PRESERFLO™ MicroShunt XI are ophthalmologists/ophthalmic surgeons specialized in the treatment of glaucoma (including surgeons specialized in anterior segment and cataract surgery) who have been trained to use the device. No biospecimens are collected in this study and no control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include adult patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the subject is included in the study and relevant data will be recorded during scheduled clinical visits. Participation in this study is entirely voluntary;', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, age 18 to 85 years, inclusive\n2. Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications\n3. Patient willing to comply with study requirements\n4. Patient who has signed an approved informed consent form\n\nExclusion Criteria:\n\n1. Angle closure glaucoma\n2. Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)\n3. Active iris neovascularization\n4. Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)\n5. Vitreous in the anterior chamber\n6. Presence of an anterior chamber intraocular lens (ACIOL)\n7. Intraocular silicone oil\n8. Need for glaucoma surgery combined with other ocular procedures (e.g., cataract surgery with IOL implantation) or anticipated need for additional ocular surgery during the investigational period\n9. Central corneal thickness that is less than 450 microns or greater than 620 microns\n10. Previous cilioablative procedure\n11. Neovascular glaucoma\n12. Uveitic Glaucoma\n13. Pseudoexfoliative or pigmentary glaucoma\n14. Chronic inflammation\n15. Previous incisional ophthalmic surgery within 6 months prior to study\n16. Enrolled in this or another study (only one eye can participate in this study) or completed their participation in another study within 30 calendar days of the screening exam\n17. Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the patient at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the Protocol"}, 'identificationModule': {'nctId': 'NCT07235592', 'briefTitle': 'PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen SAS'}, 'officialTitle': 'Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': '200011001SW'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Microshunt XI treatment group', 'description': 'MicroShunt XI will be surgically implanted in eyes of patients with primary open angle glaucoma where intra ocular pressure (IOP) remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.', 'interventionNames': ['Device: Microshunt XI']}], 'interventions': [{'name': 'Microshunt XI', 'type': 'DEVICE', 'otherNames': ['Intervention Model/Device: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival/Tenon implantation.'], 'description': 'The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device', 'armGroupLabels': ['Microshunt XI treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'contacts': [{'name': 'Prof. Clemens Vass', 'role': 'CONTACT'}], 'facility': 'AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'name': 'Prof. Ingeborg Stalmans', 'role': 'CONTACT'}], 'facility': 'Glaucoma Clinic, UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Düsseldorf', 'country': 'Germany', 'contacts': [{'name': 'Dr Karsten Klabe', 'role': 'CONTACT'}], 'facility': 'Internationale Innovative Opthalmochirurgie GbR', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Tübingen', 'country': 'Germany', 'contacts': [{'name': 'Prof. Bogomil Voykov', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Tübingen, Department für Augenheilkunde', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Rome', 'country': 'Italy', 'contacts': [{'name': 'Dr Francesco Oddone', 'role': 'CONTACT'}], 'facility': 'Irccs Fondazione G. B. Bietti', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Turin', 'country': 'Italy', 'contacts': [{'name': 'Prof. Antonio Fea', 'role': 'CONTACT'}], 'facility': 'Policlinico Universitario Molinette', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Maastricht', 'country': 'Netherlands', 'contacts': [{'name': 'Prof. Henny Beckers', 'role': 'CONTACT'}], 'facility': 'Universiteitskliniek voor Oogheelkunde Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Lisbon', 'country': 'Portugal', 'contacts': [{'name': 'Prof. Luis Abegao Pinto', 'role': 'CONTACT'}], 'facility': 'ULS Santa Maria, Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'San Carlos', 'country': 'Spain', 'contacts': [{'name': 'Prof. Julián García-Feijóo', 'role': 'CONTACT'}], 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 36.48333, 'lon': -6.2}}, {'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Prof. Kin Sheng Lim', 'role': 'CONTACT'}], 'facility': "Guy's and St. Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Prof. Gus Gazzard', 'role': 'CONTACT'}], 'facility': 'Moorfields Eye Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Study Director / Medical Monitor Raymund Angeles', 'role': 'CONTACT', 'email': 'raymund.angeles@santen.com', 'phone': '510-368-9861'}, {'name': 'Santen SAS Clinical Operations', 'role': 'CONTACT', 'email': 'bianca.groenendijk@santen.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}