ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology (CHEST) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The time measured from post-mastectomy to hemostasis for each operated breast.
研究概览
简要总结
A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE DEVICE EFFICACY BETWEEN THE HELIXAR ELECTROSURGICAL GENERATOR (HEG) VS. CONVENTIONAL ELECTROSURGICAL COAGULATION (CEC) FOR CUTTING AND/OR COAGULATION OF TISSUE DURING MASTECTOMY PROCEDURES
详细描述
The objective of this study is to evaluate device efficacy between the HelixAR Electrosurgical Generator (HEG) and Conventional Electrosurgical Coagulation (CEC) Systems for cutting and/or coagulation of tissue during mastectomy procedures and reconstructive surgery.
The study is designed and powered to demonstrate the superiority of the HEG to CEC in relation to a key efficacy measure: post-mastectomy procedure time to hemostasis. Secondary outcome measures include: infection, drain duration, total drain output, blood loss, and device related adverse events. These outcomes will be evaluated in a controlled population undergoing mastectomy procedures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age;
- •Capable and willing to give informed consent;
- •Acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. All subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest.
排除标准
- •Advanced refusal of blood transfusion, if necessary;
- •Active systemic or cutaneous infection or inflammation;
- •Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- •Uncontrolled diabetes mellitus
- •Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- •Severe co-existing morbidities having a life expectancy of less than 30 days;
- •Currently involved in any other investigational clinical studies that could influence outcomes;
- •Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- •Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- •Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- •Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.
研究组 & 干预措施
HelixAR Electrosurgical Generator (HEG)
Argon gas and high frequency electrical current ablation device
干预措施: Ablation (Device)
Conventional Electrosurgical Coagulation (CEC) Systems
Standard Bovie electrosugical device without argon gas
干预措施: Ablation (Device)
结局指标
主要结局
The time measured from post-mastectomy to hemostasis for each operated breast.
时间窗: Inter-operative
time
次要结局
- drain output(up to two weeks post surgery)