NCT02423174撤回不适用
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
Domain Surgical, Inc.0 个研究点开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
研究概览
简要总结
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed rectal cancer to the lower two-thirds of the rectum (higher and T2 N0 or N+)
- •Amenable for standard surgery procedures using electrocautery, argon beam, lasers or other conventional tissue removal modalities
- •ECOG status ≤ 2
- •Life expectancy >3 months
- •Age ≥ 18 years old
- •Age ≤ 80 years old
- •Ability to provide written informed consent and HIPAA forms prior to admission to this study
- •Willingness to meet all of the expected requirements of this clinical protocol
排除标准
- •Patient with metastasis
- •History of radiotherapy or chemotherapy for the treatment of rectal cancer
- •Uremia - BUN>40
- •Hemodialysis
- •Existing urinary or fecal incontinence
- •Pregnant or lactating
- •Previously diagnosed coagulopathy or bleeding diathesis
- •Currently, or within the previous 10 days prior to surgery, taking any medications that would produce bleeding diathesis including but not limited to, Plavix, warfarin, NSAIDs, clopidogrel, ticlopidine or valproic acid
- •History of significant cardiac disorders that would necessitate special fluid management protocols
- •History of acute myocardial infarction and/or acute angina
- •INR >1.4 in the 24 hours prior to surgery
- •PTT >40 in the 24 hours prior to surgery
- •Platelet count <100K in the 24 hours prior to surgery
结局指标
主要结局
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
时间窗: 1 day after surgery
Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System
次要结局
- Post-operative Drainage(Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days)
- Onset of urinary or fecal incontinence(Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days)
- Duration of Procedure(During Procedure)
- Duration of TME resection(During procedure)
- Evaluation of post-operative complications(12 weeks after surgery)
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