NCT02162628终止不适用
Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 14
- 主要终点
- Rate of device and procedure related adverse events
研究概览
简要总结
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female at least 18 years of age
- •Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and Bp ≥0 and C≥ -1/2 tvl
- •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 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 a 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 a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, 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(s)
结局指标
主要结局
Rate of device and procedure related adverse events
时间窗: 36 Month
Recurrence of Prolapse
时间窗: 36 Month
Recurrent prolapse is measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
次要结局
- Recurrence of prolapse(36 Month)
- Rates of other adverse events(36 months)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
不适用
Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ ProlapsePelvic Organ ProlapseNCT03271294Michigan Institution of Women's Health PC80
已完成
不适用
Patient Controlled Tissue Expansion for Breast ReconstructionBreast CancerNCT01425268AirXpanders, Inc.158
已完成
不适用
Assessment of Effectiveness Ex-Press Surgery ModificationGlaucoma, Open-AngleGlaucoma SecondaryGlaucoma, Primary Open AngleNCT03800589Military Institute od Medicine National Research Institute186
Unknown
不适用
Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ ProlapsePelvic Organ ProlapseNCT02465710National Taiwan University Hospital350
已完成
不适用
Comparative Study of Mesh Versus No Mesh in Prolapse SurgeryVaginal ProlapseCystoceleNCT00153257Centre Hospitalier Universitaire de Nīmes162