Status:
TERMINATED
Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Scleral Thinning
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of ...
Detailed Description
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
Eligibility Criteria
Inclusion
- Male or female, aged 18 to 80 years.
- Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
- Patient with loss of substance \< 3cm2.
- Patient able to understand, sign and date the informed consent form.
- Patient who is a member or a beneficiary of a national health insurance plan.
Exclusion
- Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
- Patients with uncontrolled infectious risk.
- Patient with an autoimmune disease.
- Person deprived of liberty by a judicial or administrative decision.
- Person under forced psychiatric care.
- Person admitted to a health or social institution for purposes other than the research.
- Adult subjected to a legal protection measure or unable to express his / her consent.
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05302609
Start Date
July 4 2022
End Date
February 21 2024
Last Update
November 14 2024
Active Locations (2)
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1
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69004
2
Hôpital Pasteur 2 - CHU de NICE
Nice, France, 06000