NCT00923338已完成不适用
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has signed and dated the informed consent.
- •Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.
- •Patient agrees to follow-up schedule.
- •Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.
- •Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.
排除标准
- •Patient is not medically fit enough for surgery under general or spinal anesthesia.
- •Patient is a "mature minor" as defined by Ugandan law.
- •Patient is pregnant, breastfeeding or planning further pregnancy during the study period.
- •Patient has physical allergies or cultural objections to the receipt of porcine products.
- •Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.
- •Patient has spina bifida or other neural tube defect.
- •Patient has interstitial cystitis or other chronic pelvic pain syndrome.
- •Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract.
- •Patient presents with clinically diagnosed sepsis (for whatever reason).
- •Patient has concomitant ureterovaginal fistula.
结局指标
主要结局
Adverse Events
时间窗: 4 months
Fistula
时间窗: 4 months
次要结局
- Improvement in quality of life(4 months)
研究者
研究点 (1)
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