Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants (EverPatch)
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ClinicalTrials.gov Identifier: NCT05469867 |
Recruitment Status :
Active, not recruiting
First Posted : July 22, 2022
Last Update Posted : February 9, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 18, 2022 | ||||
First Posted Date ICMJE | July 22, 2022 | ||||
Last Update Posted Date | February 9, 2023 | ||||
Actual Study Start Date ICMJE | August 16, 2022 | ||||
Estimated Primary Completion Date | March 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety Assessment [ Time Frame: Up to 12 months ] The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation will be recorded
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Performance Assessment [ Time Frame: 6 & 12 months post-op. ] Tube or suture exposure will be detected by slit-lamp Biomicroscopy throughout the entire follow up period and incidence will be calculated. Prevention of tube or suture exposure associated with conjunctival erosion and graft melting should be demonstrated in at least 90% of the patients.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants | ||||
Official Title ICMJE | A Single Arm, Pivotal, Open Label, Multi-centre Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat EverPatch, A Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants | ||||
Brief Summary | This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants. | ||||
Detailed Description | A single arm, pivotal, open label, multi-centre clinical investigation to evaluate the clinical safety and performance of the CorNeat EverPatch, a synthetic tissue substitute for concealment of artificial ocular implants. Subjects will sign a consent form and will be assessed for eligibility based on clinical examinations and medical history. Upon eligibility verification, subjects will be implanted with the investigational device as part of an ophthalmic surgery in which a concealment of an artificial implant is required. Clinical examinations at follow up will include slit lamp biomicroscopy, assessment of visual acuity and intra ocular pressure, and recording of concomitant medications and any safety issues. Follow up visits will be performed at 1 week, 1-, 2-, 3-, 6-, 9- and 12-months post-op. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Device: CorNeat EverPatch
The CorNeat EverPatch will be implanted subconjunctivally over an ocular implant (e.g. glaucoma shunt, exposed suture tags) and fixed to the eye wall. The overlying conjunctiva will be closed over the patch.
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Study Arms ICMJE | Experimental: Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants
Intervention: Device: CorNeat EverPatch
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 1, 2024 | ||||
Estimated Primary Completion Date | March 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, France, Georgia | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05469867 | ||||
Other Study ID Numbers ICMJE | DMS-34948 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | CorNeat Vision Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | CorNeat Vision Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | CorNeat Vision Ltd. | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |