EVA Nexus Vitrectomy Device Field Observation Study
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).
1 other identifier
observational
250
1 country
1
Brief Summary
determine the safety and effectiveness of the device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2021
CompletedFirst Submitted
Initial submission to the registry
December 24, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJuly 5, 2022
June 1, 2022
10 months
December 24, 2021
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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
Interventions
Eva Nexus vitrectomy device
Eligibility Criteria
Patients that are scheduled for intra-ocular surgery regardless of the indication: * Vitrectomy surgery * Cataract surgery * Vitrectomy combined with cataract surgery
You may qualify if:
- Patients that are scheduled for intra-ocular surgery regardless of the indication:
- Vitrectomy surgery
- Cataract surgery
- Vitrectomy combined with cataract surgery
- In case of (combined) vitrectomy: primary or repeat vitrectomy
- General or retrobulbar anesthesia, the latter can be combined with sedation
- Patients aged ≥ 18 years
You may not qualify if:
- Patients aged \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
Related Publications (1)
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.
PMID: 38915097DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Stalmans, Phd
UZ Leuven
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2021
First Posted
February 8, 2022
Study Start
May 22, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
July 5, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share