NCT03436979已完成不适用
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study
Pop Medical Solutions15 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- A composite of the Pelvic Organ Prolapse Quantification (POP-Q) C point score, patient-rated symptom of vaginal bulging after vaginal colpopexy performed using the NeuGuide™ and the absence of further surgical therapy for uterine prolapse.
研究概览
简要总结
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
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
- 36 Years 至 84 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with POP-Q C point greater than (-) 1 cm.
- •Patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study.
- •Non-pregnant female (female of child bearing potential must have a negative pregnancy test).
- •Patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments.
- •Patient is able to complete written questionnaires.
- •Patient is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone.
排除标准
- •Known diagnosis of reproductive tract abnormalities.
- •Prior pelvic radiation therapy, any malignancy or active pelvic inflammatory disease.
- •Known history of severe Pelvic Inflammatory Disease (PID).
- •Prior total hysterectomy.
- •Prior pelvic prolapse surgery using synthetic mesh.
- •Pathological PAP in the past year.
- •Moderate or severe bacterial cervicitis.
- •Moderate or severe pelvic pain (> 3 on VAS).
- •Severe morbid obesity (BMI >45).
- •Temperature > 38°C (oral or equivalent), sepsis, or active infection requiring IV anti-microbial treatment.
- •Significant cognitive impairment.
- •Active malignancy other than non-melanoma skin cancer.
- •Planned surgery (more than a minor one) in the next 30 days.
- •Patient has a known hypersensitivity to device materials (Nickel, suture material).
- •Moribund patient or patient with severe or deteriorating damage in critical body systems.
- •Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
- •Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
结局指标
主要结局
A composite of the Pelvic Organ Prolapse Quantification (POP-Q) C point score, patient-rated symptom of vaginal bulging after vaginal colpopexy performed using the NeuGuide™ and the absence of further surgical therapy for uterine prolapse.
时间窗: 12 months
Primary composite performance outcome
The number of device / procedure related Serious Adverse Events (SAE).
时间窗: 30 days
Primary safety of surgical implantation as reflected by adverse events
The number of Serious Adverse Events and Adverse Events.
时间窗: 12 months
Primary safety of NeuGuide treatment as reflected by adverse events
次要结局
- The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen(36 months)
- Change in mean POP-Q C point score from baseline (cm).(36 months)
- The time utilization of staff performing the NeuGuide procedure.(one month)
- Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.(36 months)
- Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.(12 months)
研究者
研究点 (15)
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