First-in-human Open Label Feasibility Study to Assess the Safety of TIPS Microspheres in Perianal Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Phase of Investigation: First-in-human feasibility study
Objectives: Primary objective: Demonstration that TIPS microspheres do not compromise the clinical condition or safety of the patient.
Secondary objective: To demonstrate that TIPS microspheres facilitate natural healing in the context of perianal fistula.
Type of Investigation: First-in-human single site, open label, feasibility study to assess the safety of TIPS microspheres in perianal fistulas and indicative functionality.
Investigation design and methods: First-in-human single delivery of a bioabsorbable device to treat perianal fistula. A standard of care internal flap procedure performed to close the internal fistula opening and up to 300 mg of TIPS microspheres will be inserted into each perianal fistula. Participants will be assessed for healing, inflammation, abscess, sepsis, pain and continence by clinical assessments, blood tests, MRI and questionnaires.
详细描述
TIPS microspheres are manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) under Good Laboratory Practice (GLP) conditions.
Microspheres will be delivered into the fistula tract using the following procedure:
i) Tract identification with special emphasis on locating the internal and external openings using a fistula probe.
ii) Curettage to remove epithelium lining the tract and cleaning by irrigation with hydrogen peroxide and saline.
iii) Closure of the internal opening by means of a rectoanal advancement flap. iv) Following device kit instructions, prepare a paste of TIPS microspheres with GranuGel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •Cryptoglandular perianal fistula
- •High and low simple trans-sphincteric fistula
排除标准
- •Secondary fistula, including Crohn's disease, carcinoma, radiotherapy, tuberculosis
- •Evidence of branching fistula anatomy or cavity on MRI
- •Inter-sphincteric fistula
- •Low trans-phincterictrans-sphincteric fistula amenable to simple fistulotomy
- •Immunosuppressed patients
- •Participants less than 18 years of age
- •Unable to consent
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Within 9 months of device implantation
Safety as defined by morbidity, measured by occurrence of adverse events / reactions, in particular: perianal sepsis, perianal abscess, or reoperation due to sepsis
次要结局
- Clinical evidence of fistula healing(9 months after device implantation)