Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05229094
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2021-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVA Nexus Vitrectomy Device Field Observation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-26', 'size': 1085641, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-21T11:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2021-12-24', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the intra-operative safety of a new surgical device', 'timeFrame': '2 days', 'description': 'specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the possible reduction of total surgical time', 'timeFrame': '1 day', 'description': 'The time that was required to prepare the EVA Nexus will be recorded (connecting of supplies + priming).'}, {'measure': 'To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure', 'timeFrame': '2 days', 'description': 'The surgical parameters include a range of data collected on the following:\n\nAspiration Irrigation / Infusion BSS Usage Vitrectomy Ultrasound Illumination Diathermy Micro-injection Silicone oil injection / extraction Laser'}, {'measure': 'To evaluate possible (S)AE that may be related to the use of the surgical platform.', 'timeFrame': '2 days', 'description': "Rarely, adverse events (AE) that are related to the surgery may only become visible the day after the surgery. A postoperative check of the eye at the day after the surgery will be performed to determine the presence of such AE's."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retina Disorder', 'Vitreous Disorder']}, 'referencesModule': {'references': [{'pmid': '38915097', 'type': 'DERIVED', 'citation': 'Peter S. Clinical trial to test the safety of the EVA Nexus surgical platform. Int J Retina Vitreous. 2024 Jun 24;10(1):45. doi: 10.1186/s40942-024-00563-3.'}]}, 'descriptionModule': {'briefSummary': 'determine the safety and effectiveness of the device.', 'detailedDescription': 'To perform a field observation study using the newly developed EVA Nexus vitrectomy device.\n\nPatients that are scheduled for intra-ocular surgery regardless of the indication:\n\n* Vitrectomy surgery\n* Cataract surgery\n* Vitrectomy combined with cataract surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are scheduled for intra-ocular surgery regardless of the indication:\n\n* Vitrectomy surgery\n* Cataract surgery\n* Vitrectomy combined with cataract surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that are scheduled for intra-ocular surgery regardless of the indication:\n* Vitrectomy surgery\n* Cataract surgery\n* Vitrectomy combined with cataract surgery\n* In case of (combined) vitrectomy: primary or repeat vitrectomy\n* General or retrobulbar anesthesia, the latter can be combined with sedation\n* Patients aged ≥ 18 years\n\nExclusion Criteria:\n\n* Patients aged \\< 18 years'}, 'identificationModule': {'nctId': 'NCT05229094', 'briefTitle': 'EVA Nexus Vitrectomy Device Field Observation Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'EVA Nexus Field Observation Study. A Monocentric, Academic Field Observation Study of a Prototype of a New CE-labeled Vitrectomy Device Developed by DORC BV (The Netherlands).', 'orgStudyIdInfo': {'id': '64913'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eva Nexus', 'type': 'DEVICE', 'description': 'Eva Nexus vitrectomy device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Peter Stalmans, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}