MASERATI 100 - A Prospective, Multi-center, Post-mArket, Single-arm obsERvATIonal Study to Collect Clinical Outcome Data on the Use of Permacol™ Collagen Paste in the Treatment of Anorectal Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Fistula Healing in Patients at 6 Months Following Surgery
研究概览
简要总结
This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas.
The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.
详细描述
The study will enroll 100 subjects at up to 10 centers throughout the European Union. The expected duration of the enrollment period is approximately 9 months. The duration of each subject's participation in the study will be approximately one year. However, at sites where the routine follow-up period is greater than one year, subjects may be followed for up to 36 months at their surgeon's discretion if they agree to it.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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 or female subjects age 18 or older
- •Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin
排除标准
- •History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis)
- •Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas
- •Indication of an actively infected fistula/abscess (acute sepsis)
结局指标
主要结局
Fistula Healing in Patients at 6 Months Following Surgery
时间窗: 6 months
Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
次要结局
- Fistula Healing in Patients at 3 and 12 Months Following Surgery(3 months and 12 months)
- Participant Response to Quality of Life EQ-5D Questionnaire(Baseline, and 3 months, 6 months and 12 months post op)
- Fecal Incontinence(3 months, 6 months and 12 months)
- Patient Satisfaction Between the First and Last Post-operative Visit(Between the first and last visits)
- Pain(Baseline, 1 month, 3 months, 6 months and 12 months)