Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Type and incidence of adverse events (AE) and serious adverse events (SAE)
研究概览
简要总结
The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 65 years.
- •Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease.
- •Patient with an upper transsphincteric or lower transsphincteric fistula.
- •Patient presenting fistula with or without intersphincteric diverticula.
- •Fistula effectively drained with a seton.
- •Informed and consenting patient.
- •Patient who is a member or a beneficiary of a national health insurance plan.
排除标准
- •Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
- •Patients who have had more than one failed obstruction technique.
- •Patient with more than one internal orifice.
- •Patient with an MRI proven abscess.
- •Patient with an uncontrolled infection.
- •Patient with a contraindication to anesthesia.
- •Person deprived of liberty by a judicial or administrative decision.
- •Adult subjected to a legal protection measure or unable to express his / her consent.
研究组 & 干预措施
SygeLIX-F + SygeLIX-G
Combination of SygeLIX-F, a plug made of an assembly of umbilical cord lining and Wharton's jelly in the form of a cylinder of porous structure, and SygeLIX-G, a Wharton's jelly gel reconstituted in a syringe.
干预措施: SygeLIX-F + SygeLIX-G (Biological)
结局指标
主要结局
Type and incidence of adverse events (AE) and serious adverse events (SAE)
时间窗: Through study completion (45 days)
Evaluation of intensity of perineal inflammation following treatment
时间窗: Through study completion (45 days)
Scoring of pain (0 = no pain, 10 = worst pain possible), redness (0 = no redness, 4 = redness covering an area \> 5 cm), edema (0 = no edema, 4 = area completely swollen), ulceration (0 = no ulceration, 4 = ulcer larger than 1 cm).
Rate of plug expulsion and surgical revision due to complications
时间窗: Through study completion (45 days)
次要结局
- Evaluation of surgical technique(Time of investigational products surgical implantation (Day 0))
- Plug integration(30 days, 45 days)
- Cessation of fistula flow(45 days)