NCT07035925招募中不适用
Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
ECM Therapeutics, Inc.4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Adverse Events
研究概览
简要总结
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
详细描述
ECMT-100 is a colloidal hydrogel derived from extracellular matrix (ECM), formulated to adhere to sub-epithelial soft tissue and allow for filling of anorectal fistulas to reinforce and promote fistula tract closure. ECMT-100 is a medical device and should be administered via catheter within the fistula tract following curettage of the tract, with draining setons used preoperatively.
ECMT-100 is a mucoadhesive hydrogel composed of ECM formulated to adhere to the gastrointestinal mucosa, fill the transsphincteric fistula tract, and promote tract closure by allowing for timely host tissue integration without fecal incontinence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects at least 18 years of age.
- •Provide informed consent
- •Non-pregnant females
- •Clinical diagnosis of 1 high transsphincteric anorectal fistula, with 1 internal opening and 1-2 external openings, with a single seton in place.
- •Seton placement for a minimum of 3 months
- •Willingness to participate in post-operative follow-up evaluations.
排除标准
- •Inability to provide informed consent.
- •Medical history of Crohn's disease/Ulcerative Colitis.
- •Subjects with multiple fistula tracts (defined as >1 internal opening and/or >2 external openings), secondary tracts, horseshoe fistulas, J-pouch fistulas, superficial fistulas, ano/recto-vaginal fistulas or rectourethral fistulas.
- •Previous fistulotomy/fistulectomy at the target treatment site (a history of these procedures at other locations is not exclusionary).
- •Fistula of traumatic origin including obstetric.
- •Evidence of ongoing local infection.
- •Evidence of active abscess at the time of treatment.
- •Chronic disease such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes (as determined by A1C reading from past 6-12 months), or any chronic illness that may interfere with participation in this study.
- •Active and unstable disease state or infection anywhere in the body per investigator's evaluation and determination.
- •Autoimmune disease that is not stable.
- •Subjects who are immunocompromised such as known human immunodeficiency virus (HIV) or currently receiving chemotherapy or radiation therapy.
- •Ongoing use of antiplatelet drugs. Subjects may be included in the study if antiplatelet drugs have been stopped for 5 to 7 days prior to surgery.
- •Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
- •Pregnancy
- •Previous history of radiation therapy in the area of the fistula.
- •History of collagen disease.
- •Known allergy to porcine products.
- •Religious objection to use of porcine products.
结局指标
主要结局
Adverse Events
时间窗: 12 months from treatment
Number of Adverse Events
次要结局
- Changes in Fecal Incontinence(12 months from treatment)
- Changes in Quality of Life(12 months from treatment)
- Percentage of Subjects in whom external openings of the fistula have closed(12 months from treatment)
研究者
研究点 (4)
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