NCT01827774已完成不适用
A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Rate of recurrence of pelvic organ prolapse
研究概览
简要总结
The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
- •POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
- •At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)
排除标准
- •Age < 18 years
- •BMI > 40
- •Not medically fit for transvaginal surgery under general or spinal anesthesia
- •Active UTI at the time of the index procedure as determined by urine culture
- •Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
- •Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse
- •A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
- •Currently planned obliterative surgical repair for pelvic organ prolapse
- •Systemic infection at the time of surgery
- •Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents
- •Pregnant, breastfeeding or planning pregnancy during the study period
- •Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos)
- •Physical allergies or cultural objections to the receipt of porcine products
- •Life expectancy of less than 12 months
- •Ongoing participation in an investigational device or drug trial
- •Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome)
- •Active vaginal infection at the time of the index procedure
- •History of pelvic inflammatory disease
研究组 & 干预措施
Surgisis® Soft Tissue Graft
Experimental
干预措施: Surgisis® Soft Tissue Graft (Device)
结局指标
主要结局
Rate of recurrence of pelvic organ prolapse
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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