Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Estimated blood loss
研究概览
简要总结
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.
详细描述
Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 65 years
- •Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
- •Eligible for hysterectomy
- •Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure
排除标准
- •Large uterus size over 16 weeks of gestational age
- •Cervical or intraligamentary fibroids
- •Severe endometriosis (stage 3 or 4)
- •Suspected malignancy of the uterus or adnexa
- •Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
- •Previous pelvic surgery ≥ 3 times
- •Not suitable for laparoscopic surgery
结局指标
主要结局
Estimated blood loss
时间窗: through study completion, an average of 1 year
Operative procedure time
时间窗: through study completion, an average of 1 year
Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites
次要结局
- Device evaluation score(through study completion, an average of 1 year)
- Adverse events(within 6 weeks after intervention)
- Estimated medical cost of device(within 6 weeks after intervention)
研究者
Hyun Park
Professor
CHA University