Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Percentage of Tissue Removed
研究概览
简要总结
This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.
详细描述
A retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. Four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type I (mostly within the cavity) and type II (< 40% within the cavity) submucous myomas. Percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. Each of the four treating physicians also evaluated device performance using a 10 point scale (1 = "poor" and 10 = "excellent").
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •at least 18 years old
- •treated for intra-uterine submucosal fibroids (Type 0 or 1 myomas and/or polyps using the Interlace 1st generation morcellator device.
排除标准
- 未提供
结局指标
主要结局
Percentage of Tissue Removed
时间窗: immediately post-treatment
mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.
次要结局
- Treatment Time Per Patient(at time of treatment)
- Fluid Volume Per Procedure(at time of treatment)
- Fluid Deficit Per Procedure(at time of treatment)
- Resected Tissue Weight Per Patient(at time of treatment)
- Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score(2-3 months post treatment)
- Adverse Events(2-3 months post-treatment)