NCT05695989已完成不适用
Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Levita Magnetics3 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Adverse Events- Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
详细描述
Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Subject is at least 18 years of age
- •Subject is scheduled to undergo elective laparoscopic procedure
- •Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures
排除标准
- •• Subjects with pacemakers, defibrillators, or other electromedical implants
- •Subjects with ferromagnetic implants
- •Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
- •Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
- •Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
- •Subject is pregnant or wishes to become pregnant during the length of study participation
- •Subject is not likely to comply with the follow-up evaluation schedule
- •Subject is participating in a clinical trial of another investigational drug or device Prisoner or under incarceration
结局指标
主要结局
Adverse Events- Safety
时间窗: 30 days
Adverse events related to the device
次要结局
- Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon(Surgery time)
- Conversion Rate to Open Surgery(Surgery time)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of the Levita Robotic PlatformBariatric Surgery CandidateCholelithiasesOther DiseaseNCT05353777Levita Magnetics48
已完成
不适用
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic SurgerySquamous Cell Carcinoma of the OropharynxSquamous Cell Carcinoma, Unknown PrimaryNCT06112535CMR Surgical Ltd60
终止
不适用
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the HipDegenerative Joint Disease of the HipNCT01982266Biomimedica, Inc4
已完成
不适用
Single-port Robotic Transanal Total Mesorectal ExcisionRectal Cancer PatientsNCT06591572Daping Hospital and the Research Institute of Surgery of the Third Military Medical University20
尚未招募
不适用
To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection Combined With Immediate Breast Reconstruction in Breast CancerBreast CancerNCT06706726The First Affiliated Hospital with Nanjing Medical University40