NCT07021742招募中不适用
BioHealx® Anal Fistula Device Post Market Surveillance Study
Signum Surgical USA Inc.7 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Successful Closure Repair
研究概览
简要总结
This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years
- •Presence of Single Continuous Anal Fistula presenting for initial curative surgery
- •Failed or Recurrent Anal Fistula Closure
- •Minimum of 6-weeks of draining seton placed prior to procedure.
- •Availability for follow-up contacts and willingness to complete the Informed Consent.
排除标准
- •Fistula tract shorter than 2cm
- •Complex fistula tract (branching)
- •Body Mass Index > 35
- •Known uncontrolled diabetes or other systemic condition associated with impaired healing
- •Known HIV-positive or immunocompromised
- •Rectal prolapse
- •Pregnancy
- •Rectal / fistula malignancy
- •Crohn's disease
- •Ulcerative proctitis
- •Hidradenitis suppurativa of the anal region
- •Pilonidal sinus disease
- •Presence of hemorrhoid Involving fistula site
- •Continuous use of anti-inflammatory
- •Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
- •Active infection or abscess involving fistula site
- •Known allergy to PLGA material
- •Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
- •Treatment with an investigational drug or medical device in the past 30 days
研究组 & 干预措施
BioHealx
Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device.
干预措施: BioHealx (Device)
结局指标
主要结局
Successful Closure Repair
时间窗: 12 Months
Successful closure repair of the anal fistula as determined by complete healing, i.e., internal and external opening closed (no evidence of an external opening present) without drainage
Non-Recurrence Incidence
时间窗: 24 and 36 Months
Non-recurrence incidence determined by continued closure of the external fistula opening.
次要结局
- Fecal Incontinence Quality of Life(6 Months, 9 Months, 12 Months, 24 Months, 36 Months)
- Fecal Incontinence Severity Index (FISI)(6 Month, 9 Month, 12 Month, 24 Month, 36 Month)
- Health Related Quality of Life(6 Months, 9 Months, 12 Months, 24 Months, 36 Months)
- Pain Score(6 Months, 9 Months, 12 Months, 24 Months, 36 Months)
- Rescue Analgesic and Therapeutic Antibiotic Use(6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months)
研究者
研究点 (7)
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