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determine the safety and effectiveness of the device.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eva Nexus | Device | Eva Nexus vitrectomy device |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 day |
| To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are scheduled for intra-ocular surgery regardless of the indication:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, Phd | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38915097 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2021 | Jun 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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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 |
| 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. | 2 days |