Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure.
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.
详细描述
This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1. 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 18 years and older
- •Indicated for Laparoscopic Hysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)
排除标准
- •History of Human Immunodeficiency Virus (HIV)
- •History of Hepatitis C
- •History of diabetes that, in the opinion of the investigator, may delay healing
- •Current use of systemic corticosteroids
- •Active infection of genitals, vagina, cervix, uterus or urinary tract
- •Active bacteremia, sepsis or other active systemic infection
- •Presence of Sexually Transmitted Infection (STI)
- •Evidence of pelvic inflammatory disease (PID)
- •Known clotting defects or bleeding disorders
- •Hemoglobin < 8 g/dL
- •Metastatic disease
- •On anticoagulant therapy
- •Participation in another interventional trial
- •Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
- •Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
- •Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
- •Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
- •Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
- •Intra-operative: Cases requiring conversion to laparotomy prior to study intervention
研究组 & 干预措施
Test Article - Zip-stitch Clips
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
干预措施: Zip-stitch(R) (Device)
Reference Group
Will not be comparative against the test article, but will be performed for reference and safety.
干预措施: Reference suture (Device)
结局指标
主要结局
Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure.
时间窗: This will be evaluated through six weeks post operative.
Frequency of implant passing
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.
时间窗: This will be evaluated through six-weeks post-operative.
Frequency of vaginal cuff dehiscence
次要结局
- Number of Participants With Successful Vaginal Cuff Closure(Performed at one week, six weeks, and six months after surgery)
- Comparison of Number of Participants With Implant Passing - Test to Reference(Evaluated at six weeks and six months post-operative)
- Number of Participants With Vaginal Cuff Healing(Performed at six weeks, and six months after surgery)
- Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety(Evaluated through six-month follow-up)
- Comparison of Incidence of Adverse Events - Test to Reference(Evaluated through six-month follow-up)
- Number of Participants With Non-increase in Dyspareunia at Follow-up(Evaluated through six-month follow-up)
- Number of Participants With Non-increase in Pain at Follow-up(Evaluated through six-month follow-up)