Back to resultsUse of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Primary Purpose
Enucleated; Eye, Eye Cancer
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
SclerFIX
Sponsored by
About this trial
This is an interventional treatment trial for Enucleated; Eye
Eligibility Criteria
Inclusion Criteria:
- Men or women between 45 and 85 years old, presenting an enucleation caused by malignant tumor resection.
- Oncological treatment compatibility with enucleation and intra-orbital implant.
- Surgery requiring the placement of an enucleation implant.
- Persistence of the oculomotor muscles allowing their insertion into the tissue.
- Patient with social security coverage.
- Consenting and informed patient.
Exclusion Criteria:
- Pregnant or breast-feeding women: women of childbearing age were asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Patient presenting an infectious risk (neutropenia, active local infection, immunodeficiency).
- Patient with autoimmune disease.
- Proton-therapy / radiotherapy of the eye before healing.
- Patient with oculomotor muscles invasion or non-attachment of these muscles.
- Allergy to contrast agents used in radiology.
- Patient under legal guardianship.
- Patient not benefiting from the social security cover.
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SclerFIX
Arm Description
Strip of umbilical cord lining membrane allograft wrapped around the bioceramic enucleation implant. The assembly is placed inside the void orbital cavity and the muscles are sutured to the SclerFIX strips.
Outcomes
Primary Outcome Measures
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation
Secondary Outcome Measures
Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility
Evaluation by physical examination by the surgeon of the set-up assembly and its maintenance over time with insertion of oculomotor muscles, integration of these latter, and maintenance of the movement of the implant
Evaluation of surgical wrapping and attachment with muscles
Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05236049
Brief Title
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Official Title
Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.
Detailed Description
As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enucleated; Eye, Eye Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SclerFIX
Arm Type
Experimental
Arm Description
Strip of umbilical cord lining membrane allograft wrapped around the bioceramic enucleation implant. The assembly is placed inside the void orbital cavity and the muscles are sutured to the SclerFIX strips.
Intervention Type
Biological
Intervention Name(s)
SclerFIX
Intervention Description
Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.
Primary Outcome Measure Information:
Title
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
Description
Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation
Time Frame
Through study completion (6 months)
Secondary Outcome Measure Information:
Title
Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility
Description
Evaluation by physical examination by the surgeon of the set-up assembly and its maintenance over time with insertion of oculomotor muscles, integration of these latter, and maintenance of the movement of the implant
Time Frame
7 days, 15 days, 1 month, 3 months, 6 months
Title
Evaluation of surgical wrapping and attachment with muscles
Description
Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0)
Time Frame
Time of investigational product surgical implantation (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women between 45 and 85 years old, presenting an enucleation caused by malignant tumor resection.
Oncological treatment compatibility with enucleation and intra-orbital implant.
Surgery requiring the placement of an enucleation implant.
Persistence of the oculomotor muscles allowing their insertion into the tissue.
Patient with social security coverage.
Consenting and informed patient.
Exclusion Criteria:
Pregnant or breast-feeding women: women of childbearing age were asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
Patient presenting an infectious risk (neutropenia, active local infection, immunodeficiency).
Patient with autoimmune disease.
Proton-therapy / radiotherapy of the eye before healing.
Patient with oculomotor muscles invasion or non-attachment of these muscles.
Allergy to contrast agents used in radiology.
Patient under legal guardianship.
Patient not benefiting from the social security cover.
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
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