IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.
NCT ID: NCT04409808
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
39 participants
INTERVENTIONAL
2021-09-21
2022-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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IRIS vitrectomy device
all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device
IRIS
prototype IRIS vitrectomy device.
Interventions
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IRIS
prototype IRIS vitrectomy device.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* No post-operative 8 week visit is anticipated
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Peter Stalmans, PHd MD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZ Leuven
Leuven, Vlaams Brabant, Belgium
Countries
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Other Identifiers
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S62660
Identifier Type: -
Identifier Source: org_study_id
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