Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Completion of the procedure using the Maestro Platform without conversion to a manual minimally invasive or open surgical procedure specifically due to a device failure or malfunction
研究概览
简要总结
The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 to ≤ 75 years
- •Scheduled for one of the following non-emergent laparoscopic procedure: cholecystectomy, hernia repair, appendectomy, bariatric surgery (gastric sleeve or gastric bypass), or colectomy.
- •Willing to comply with protocol-specified follow-up evaluation
- •Signed informed consent
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 participating in another investigational drug or device study that clinically interferes with the endpoints of this study;
- •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 three months of the procedure, or lactating;
- •Extreme morbid obesity (BMI greater than 45 kg/m2);
- •Patients presenting with ascites;
- •Patients presenting for emergency surgery;
- •Previous surgery in the same anatomical location;
- •Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)
研究组 & 干预措施
Procedure using the Maestro Platform
Study participants will be adults aged ≥ 18 to ≤ 75 years scheduled for a non-emergent laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy.
干预措施: Laparoscopic surgery using the Maestro Platform (Device)
结局指标
主要结局
Completion of the procedure using the Maestro Platform without conversion to a manual minimally invasive or open surgical procedure specifically due to a device failure or malfunction
时间窗: During procedure
Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications
时间窗: 30 days
次要结局
未报告次要终点