Clinical Validation Study of the Eximis CS (Contained Segmentation) System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Performance
研究概览
简要总结
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
详细描述
This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
Eligible subjects who have signed an informed consent form (ICF) will be enrolled. Subjects will be sequentially enrolled and assigned a study identification number. Surgeons will also be assigned a unique number.
Subjects will undergo the standard of care regarding all aspects of the pre-operative, surgical, and follow-up procedures. The aspect unique to this study is the capture, segmentation, and extraction of the target tissue will utilize one integrated device, the Eximis CS System, which segments tissue via segmenting wires using RF energy. The device is not intended to provide any therapeutic effect.
All subjects will be followed for safety through two post-procedure follow-up visits. One will be scheduled at a minimum of 14 days and a maximum of 21 days post-operatively. The second will be a follow-up phone call scheduled at a minimum of 30 days and a maximum of 45 days post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6 cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second longest dimension, based on preoperative assessment.
- •Pre-operative evaluation, which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.
- •Signed informed consent. Willing to adhere to protocol requirements and complete follow-up.
排除标准
- •Subject is post-menopausal, defined as amenorrhea >12 months in the absence of ovulation suppression.
- •Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
- •Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
- •Hemoglobin < 8 g/dl within 30 days prior to surgery. Subject has a current history of undiagnosed genital bleeding Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
- •Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
- •Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.
- •Concurrent participation in another therapeutic or interventional clinical trial with investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation of this study as determined by the Investigator.
- •Inability to comply with the study procedures or follow-up in the opinion of the investigator.
- •Subject is pregnant.
- •Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site exceeds 6 cm.
结局指标
主要结局
Performance
时间窗: 2 months
Percentage of procedures successfully completed with use of the Eximis CS device per the Instructions for Use and without breach of the containment bag.
次要结局
- Usability(2 months)