A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 46
- 主要终点
- Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
研究概览
简要总结
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.
详细描述
The Harmony 522 study has been terminated due to the closing of the Astora Women's Health business. No other entity will be taking responsibility for this study. The study was terminated with partial subject enrollment complete and therefore no primary or secondary data analysis can be performed. The data from this study resides in a national data base which Astora no longer has access and therefore is another reason why no data analysis can be performed. The national database is owned and managed by the American Urogynecology Society (AUGS). AUGS has access to Astora's data and will at some time in the near future publish results to physicians who are active participants in the registry. Full public disclosure of this data may not occur for a number of years and will be aggregated with data from other study sponsors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subject is female
- •Subject is at least 18 years of age
- •Subject must have documented diagnosis of posterior or posterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior prolapse that includes the apical compartment)
- •Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
- •Subject or subject's legally authorized representative is willing to provide written informed consent
- •Subject is willing and able to comply with the follow-up regimen
排除标准
- •Subject is pregnant or intends to become pregnant during the study
- •Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- •Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
- •Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- •Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- •Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
- •Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- •Subject has uncontrolled diabetes mellitus (DM)
- •Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
- •Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- •Subject is not able to conform to the modified dorsal lithotomy position
- •Subject is currently participating in or plans to participate in another device or drug study during this study
- •Subject has a known sensitivity to polypropylene
- •Subject has had previous prolapse repair with mesh in the target compartment
- •Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
结局指标
主要结局
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
时间窗: 36 months
Rate of device or procedure related serious adverse events
时间窗: 36 months
次要结局
- Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12(36 months)
- Rate of repeat surgery/revision for prolapse arising from the same site/target compartment(36 months)
- Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures(36 months)