Retina DisorderNCT05229094
EVA Nexus Vitrectomy Device Field Observation Study
An observational study of Retina Disorder and Vitreous Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
determine the safety and effectiveness of the device. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Retina Disorder, Vitreous Disorder
- What is being tested?
- Eva Nexus
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients that are scheduled for intra-ocular surgery regardless of the indication: * Vitrectomy surgery * Cataract surgery * Vitrectomy combined with cataract surgery
Who may be able to join
- 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
Who cannot join
- Patients aged < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
determine the safety and effectiveness of the device.
Read the detailed description
To perform a field observation study using the newly developed EVA Nexus vitrectomy device.
Patients that are scheduled for intra-ocular surgery regardless of the indication:
- Vitrectomy surgery
- Cataract surgery
- Vitrectomy combined with cataract surgery
- Conditions
- Retina Disorder, Vitreous Disorder
- Being tested
- Eva Nexus
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eva NexusDevice
Eva Nexus vitrectomy device
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (3)
To evaluate the possible reduction of total surgical time
The time that was required to prepare the EVA Nexus will be recorded (connecting of supplies + priming).
Measured: 1 day
To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure
The surgical parameters include a range of data collected on the following:
Aspiration Irrigation / Infusion BSS Usage Vitrectomy Ultrasound Illumination Diathermy Micro-injection Silicone oil injection / extraction Laser
Measured: 2 days
To evaluate possible (S)AE that may be related to the use of the surgical platform.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start22 May 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retina DisorderStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229094
- Sponsor's protocol ID
- 64913
- Status last verified
- Jun 2022
- First submitted
- 24 Dec 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38915097
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT05229094
- Acronym / sponsor ID
- 64913
- Conditions
- Retina Disorder, Vitreous Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 22 May 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
determine the safety and effectiveness of the device.
Detailed description
To perform a field observation study using the newly developed EVA Nexus vitrectomy device.
Patients that are scheduled for intra-ocular surgery regardless of the indication:
- Vitrectomy surgery
- Cataract surgery
- Vitrectomy combined with cataract surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that are scheduled for intra-ocular surgery regardless of the indication: * Vitrectomy surgery * Cataract surgery * Vitrectomy combined with cataract surgery
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients aged < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eva NexusEva Nexus vitrectomy device | Device | – |
Primary outcome
to evaluate the intra-operative safety of a new surgical device
Time frame: 2 days
specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.
3 secondary outcomes
To evaluate the possible reduction of total surgical time
Time frame: 1 day
To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure
Time frame: 2 days
To evaluate possible (S)AE that may be related to the use of the surgical platform.
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 38915097Peter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stalmans, Phd principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retina Disorder and Vitreous Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the intra-operative safety of a new surgical device (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.