NCT01111409已完成不适用
A Prospective, Multi-Centre Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical 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
- 20
- 试验地点
- 3
研究概览
简要总结
The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).
详细描述
Assuming success of the VFIX anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the Device Run-In (DRI) subjects) will undergo the VFIX procedure to evaluate the safety and effectiveness of the VFIX device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse.
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
- •Age greater than or equal to 18 years
- •Subjects of child bearing potential have a negative blood or urine pregnancy test prior to the procedure and subject has completed childbearing
- •Subject with apical prolapse at stage II or more and requiring treatment (C should be at least -1 cm)
- •On reduction of the apical prolapse, leading edge of prolapse should be at or above the hymen
- •If applicable, subject has small/normal size uterus and there is no elongation of the cervix as determined by clinical assessment
- •The vaginal apex can reach the Sacrospinous Ligament (SSL) on exam
- •Subjects are allowed concurrent incontinence procedure as required
- •Concurrent perineal repairs and excision of excess vaginal tissue repairs as required
- •Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent
排除标准
- •Additional surgical intervention for POP repairs concurrent to the VFIX procedure (including, but not limited to sacrocolpopexy, paravaginal repair, colporrhaphy, mesh repair, etc)
- •Experimental drug or experimental medical device within 3 months prior to the planned procedure
- •Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- •Previous hysterectomy within 6 months of scheduled surgery.
- •Coagulation disorder or on therapeutic anticoagulant therapy (except aspirin) at the time of surgery
- •Nursing or pregnant
- •Presence of cancers of the vagina, cervix, or uterus
- •In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol
研究组 & 干预措施
VFIX
Experimental
干预措施: VFIX Device (Device)
研究者
研究点 (3)
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