Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
研究概览
简要总结
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
详细描述
HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites.
The subjects will be followed at hospital charge and 6 weeks postoperatively.
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
Secondary endpoints of this clinical investigation consist of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Subject is undergoing an elective open abdominal or orthopedic lower extremity surgery;
- •Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
- •Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and
- •Subject is 21 years of age or older.
- •Subject does not have an active or suspected infection at the surgical site;
- •Subject in whom the Investigator is able to identify a target bleeding site (TBS) for which any applicable conventional means for achieving hemostasis are ineffective or impractical; and
- •Subject has a TBS with an SBSS score of 1, 2, or 3.
排除标准
- •• Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
- •Subject is undergoing a spinal surgical procedure;
- •Subject is undergoing a neurologic surgical procedure;
- •Subject is undergoing an emergency surgical procedure;
- •Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
- •Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter and/or International Normalized Ratio > 1.5 within 4 weeks of surgery;
- •Subject had chronic corticosteroid use within 2 weeks prior to surgery;
- •Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery;
- •Subject has an active or suspected infection at the surgical site;
- •Subject has had or has planned any organ transplantation;
- •Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- •Subject has ASA classification of > 4;
- •Subject has a life expectancy of less than 3 months;
- •Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
- •Subject has a documented severe congenital or acquired immunodeficiency;
- •Subject has religious or other objections to porcine or bovine components;
- •Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint implant;
- •Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and
- •Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.
研究组 & 干预措施
HEMOBLAST
All subjects will have the investigational device implanted
干预措施: HEMOBLAST Bellows (Device)
结局指标
主要结局
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
时间窗: Intraoperative
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
次要结局
- Adverse Events(6 +/- 2 weeks after implant)
- Hemostatic Within 6 Minutes(Intraoperative)
- Hemostasis Within 10 Minutes(Intraoperative)
- Hemostasis Within 3 Minutes(Intraoperative)