Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
2018年8月31日 更新者：ZSX Medical LLC
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
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.
研究概览
研究类型
介入性
注册 (实际的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Nuevo León
-
Monterrey、Nuevo León、墨西哥、64460
- Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- HIV
- Hepatitis C
- Diabetics
- Use of systemic corticosteroids
- History of pelvic irradiation
- Active infection
- History of bleeding problems/hemophilia
- Cancer
- Cases in which vaginal cuff closure is intended to be performed robotically
- Pregnant
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Device Ease of Use
大体时间：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.
|
Immediately following procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vaginal Cuff Closure
大体时间：During procedure.
|
Assessment of quality of vaginal cuff closure following uterine excision.
Performed by surgeon as operative standard of care.
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During procedure.
|
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Vaginal Cuff Closure Time
大体时间：During Procedure.
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Procedural time from uterine excision to successful vaginal cuff closure.
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During Procedure.
|
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Total Surgical Time
大体时间：During Procedure.
|
Total procedural time.
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During Procedure.
|
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Device Use Learning Curve assessed with a Surgeon Survey
大体时间：Assessed immediately following study completion during surgeon survey.
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Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.
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Assessed immediately following study completion during surgeon survey.
|
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Sexual Discomfort
大体时间：Assessed at 1 and 6 week follow-up visits.
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Measurement of subject discomfort during sexual activity following completion of surgical procedure.
Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).
|
Assessed at 1 and 6 week follow-up visits.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Dan Mazzucco, PhD、ZSX Medical LLC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年4月17日
初级完成 (实际的)
2017年6月30日
研究完成 (实际的)
2018年5月30日
研究注册日期
首次提交
2017年9月26日
首先提交符合 QC 标准的
2017年10月13日
首次发布 (实际的)
2017年10月16日
研究记录更新
最后更新发布 (实际的)
2018年9月4日
上次提交的符合 QC 标准的更新
2018年8月31日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
其他研究编号
- ZHP01-1.0
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.