Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Device Ease of Use
研究概览
简要总结
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.
Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Provision of signed and dated Informed Consent Form
- •Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
- •Female, age 18 years or older
- •Indicated for Total Laparoscopic Hysterectomy
排除标准
- •Hepatitis C
- •Diabetics
- •Use of systemic corticosteroids
- •History of pelvic irradiation
- •Active infection
- •History of bleeding problems/hemophilia
- •Cases in which vaginal cuff closure is intended to be performed robotically
研究组 & 干预措施
Single Study Site: UANL
As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy.
干预措施: Zip-Stitch Soft Tissue Closure System (Device)
结局指标
主要结局
Device Ease of Use
时间窗: Immediately following procedure
Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.
次要结局
- Total Surgical Time(During Procedure.)
- Vaginal Cuff Closure(During procedure.)
- Device Use Learning Curve assessed with a Surgeon Survey(Assessed immediately following study completion during surgeon survey.)
- Sexual Discomfort(Assessed at 1 and 6 week follow-up visits.)
- Vaginal Cuff Closure Time(During Procedure.)