Status:
TERMINATED
IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Vitrectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To perform a safety study on the prototype IRIS vitrectomy device.
Detailed Description
to determine the safety and effectiveness of the device.
Eligibility Criteria
Inclusion
- Patients that are scheduled for vitrectomy surgery, regardless of the indication
- Both vitrectomy-only and combined phaco-vitrectomy surgeries
- Primary or repeat vitrectomy
- General or local anesthesia, or combination
- All ages
- Informed consent (from parents in patients \<18 years old)
Exclusion
- Unable to obtain informed consent from patient (or from parents in children)
- No post-operative 8 week visit is anticipated
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04409808
Start Date
September 21 2021
End Date
November 7 2022
Last Update
November 16 2022
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3020