Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SclerFIX
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.
干预措施: SclerFIX (Biological)
结局指标
主要结局
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
时间窗: Through study completion (6 months)
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
次要结局
- Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility(7 days, 15 days, 1 month, 3 months, 6 months)
- Evaluation of surgical wrapping and attachment with muscles(Time of investigational product surgical implantation (Day 0))