NL-OMON32218尚未招募不适用
A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair - PROPE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •These include females who:
- •1) Have been diagnosed with one or more clinically significant anterior, apical or
- •posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher)
- •requiring surgical repair
- •2) Are > 21 years old
排除标准
- •1) The Investigator determines the subject is not a candidate for surgical repair of her
- •genital prolapse.
- •2) Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee,
- •Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
- •3) Subject has active or latent systemic infection or signs of tissue necrosis.
- •4) Subject has restricted leg motion (inability to abduct or adduct leg positioning in the
- •lithotomy position) with or without a hip replacement/prosthesis.
- •5) Subject is currently pregnant or intends to become pregnant during the study period.
- •Note: the risks and benefits of performing the procedure if the subject is planning
- •future pregnancies should be carefully considered.
- •6) Subject has had radiation therapy to the pelvic area.
- •7) Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has
- •been on cytostatic medication within the past 12 months.
- •8) Subject has a known hypersensitivity to the graft material(s).
- •9) Subject has uncontrolled diabetes.
- •10) Subject is on any medication which could result in compromised immune response,
- •such as immune modulators.
- •11) Subject was involved in any other research trial < 30 days of enrollment into this
- •12) Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this
- •13) Subject is unwilling or unable to give valid informed consent.
- •14) Subject is unwilling or unable to comply with the requirements of the protocol,
- •complete all Quality of Life questionnaires and return for all follow-up visits.
- •15) Subject is contraindicated based on intended use and warnings in the AMS PFR
- •System devices for prolapse repair Instructions for Use (IFU).
研究者
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