VitrectomyIRISNCT04409808
IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.
A study testing IRIS in people with Vitrectomy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To perform a safety study on the prototype IRIS vitrectomy device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy
- What is being tested?
- IRIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Sep 2021to 7 Nov 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Unable to obtain informed consent from patient (or from parents in children)
- No post-operative 8 week visit is anticipated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.
To perform a safety study on the prototype IRIS vitrectomy device.
Read the detailed description
to determine the safety and effectiveness of the device.
- Conditions
- Vitrectomy
- Being tested
- IRIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRISDevice
prototype IRIS vitrectomy device.
| Study group | Role | What they receive |
|---|---|---|
| IRIS vitrectomy device | Experimental | all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device Receives: Device: IRIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intra-operative adverse events that determine the safety of the surgery
complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem
Measured: Intraoperative (surgery day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start21 Sep 2021
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Why it stopped: because a device deficiency that occured in the Iris vitrectomy system (Alfa version)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, PHd MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409808
- Sponsor's protocol ID
- S62660
- Acronym
- IRIS
- Status last verified
- Sep 2021
- First submitted
- 5 May 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.
- ClinicalTrials.gov ID
- NCT04409808
- Acronym / sponsor ID
- IRIS / S62660
- Conditions
- Vitrectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because a device deficiency that occured in the Iris vitrectomy system (Alfa version)
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 1 Jun 2020 (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.
To perform a safety study on the prototype IRIS vitrectomy device.
Detailed description
to determine the safety and effectiveness of the device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRIS vitrectomy device | Experimental | Device: IRISall subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to obtain informed consent from patient (or from parents in children)
- No post-operative 8 week visit is anticipated
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 |
|---|---|---|
| IRISprototype IRIS vitrectomy device. | Device | IRIS vitrectomy device |
Primary outcome
incidence of intra-operative adverse events that determine the safety of the surgery
Time frame: Intraoperative (surgery day)
complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem
Results and safety
The study was stopped early (reason given: because a device deficiency that occured in the Iris vitrectomy system (Alfa version)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- 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 MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRIS in people with Vitrectomy, 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Nov 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 was stopped early (reason given: because a device deficiency that occured in the Iris vitrectomy system (Alfa version)). Results are not available in the source record.
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?
incidence of intra-operative adverse events that determine the safety of the surgery (time frame: Intraoperative (surgery day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2022.