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).
Sponsor study identifier
observational
250
1 country
1
Study Start
May 22, 2021
Actual (reported)Primary Completion
April 1, 2022
Actual (reported)Study Completion
April 1, 2022
Actual (reported)determine the safety and effectiveness of the device.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 22, 2021
Actual (reported)December 24, 2021
Actual (reported)February 8, 2022
Actual (reported)April 1, 2022
Actual (reported)April 1, 2022
Actual (reported)to evaluate the intra-operative safety of a new surgical device
specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.
2 days
To evaluate the possible reduction of total surgical time
1 day
To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure
2 days
To evaluate possible (S)AE that may be related to the use of the surgical platform.
2 days
Eva Nexus vitrectomy device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients that are scheduled for intra-ocular surgery regardless of the indication: * Vitrectomy surgery * Cataract surgery * Vitrectomy combined with cataract surgery
UZ Leuven
Leuven, 3000, Belgium
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.
Peter Stalmans, Phd
UZ Leuven
250 participants (actual enrollment reported by the registry).
First Submitted
December 24, 2021
First Posted
February 8, 2022
Study Start
May 22, 2021
Actual (reported)A Big Data-based Cohort Study for Cataract Patients
Contact the study team to confirm eligibility.
Primary Completion
April 1, 2022
Actual (reported)Study Completion
April 1, 2022
Actual (reported)Last Updated
July 5, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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