Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
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 (V-LOC barbed suture).
详细描述
This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic 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, six weeks, and six months. There will be an additional unblinded follow-up 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
- Triple (Participant, 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
- 是
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 18 years and older
- •Indicated for Laparoscopic Hysterectomy (may include TLH, LAVH, robotic assisted vaginal hysterectomy)
排除标准
- •History of 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 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-op: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
- •Intra-op: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
- •Intra-op: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
- •Intra-op: Cases requiring conversion to laparotomy prior to study intervention
结局指标
主要结局
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
时间窗: Six-weeks post-operative
Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.
Primary Efficacy Endpoint - Number of Participants With Implant Passing
时间窗: Six-weeks post-operative
Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks
次要结局
- Number of Participants With Vaginal Cuff Healing(Performed at one week, six weeks, and six months after surgery; reported here at six weeks)
- Number of Participants With Successful Vaginal Cuff Closure(Performed at one week, six weeks, and six months after surgery; reported here at six weeks)
- Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety(Evaluated after one week, six week, six month, and twelve month follow-up)
- Number of Participants With Non-increase in Dyspareunia at Follow-up(Six-months post-operative and again at 12 months post-operative)
- Comparison of Number of Participants With Implant Passing - Test to Reference(evaluated at six months post-operative)
- Comparison of Incidence of Adverse Events - Test to Reference(Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time)
- Number of Participants With Non-increase in Pain at Follow-up(Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase)