Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
研究概览
简要总结
The Mendaera Guidance System ("Study Device") is intended to provide guidance for precise instrument placement of common percutaneous devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. After instrument placement is achieved, investigator will perform any further clinical tasks, procedures, or treatment using standard of care.
The target population for whom this device is intended includes participants requiring ultrasound guided, percutaneous procedures.
Participants who are scheduled to undergo an ultrasound-guided procedure will be consented and enrolled in the study.
Prior to the study procedure, participants should be prepared for ultrasound-guided procedure using standard of care.
Once the investigator determines that an ultrasound-guided procedure can be performed, the compatible percutaneous instrument will be connected to the Study Device, and the investigator may proceed to utilize the System to perform targeting and depth tracking of the instrument. Once access has been achieved, Participation will conclude after the first follow-up which is anticipated to be within 24±12 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •For all procedures:
- •Age ≥ 18 years
- •Subject or legal representative is willing and able to provide informed consent
- •Subject is willing and able to comply with protocol follow-up
- •Elective procedure (non-emergent)
- •For organ access procedures, one of the following must apply:
- •Subjects for whom a percutaneous renal access for nephrostomy tube placement or percutaneous nephrolithotomy have has been indicated
- •Subjects for whom a percutaneous biopsy have has been indicated
- •Subjects for whom a percutaneous drainage (e.g. paracentesis, thoracentesis, etc.) have has been indicated
- •For vascular access procedures:
- •Subjects for whom a vascular access (arterial or venous) have been indicated
- •For pain management injections procedures:
- •Subjects for whom a pain management injection procedure has been indicated, such as intra-articular injection, nerve block pre- or post- operatively, and epidural
排除标准
- •For all procedures:
- •Subject refusal
- •Subject is unstable or potentially unstable
- •Known significant coagulopathy (INR >2.0, platelet count <100,000 / µL)
- •Previous failed attempt of same procedure
- •Suspected infection at intended needle insertion or target site
- •BMI >35 kg/m²
- •Subject has any other medical, social, or psychological problem that, in the opinion of the Investigator, precludes them from participating
- •Subject who is pregnant or intends to become pregnant during the study
- •Hypertension (subject blood pressure ≥180/110mmHg)
- •History of venous thrombosis
- •For organ access procedures:
- •Known anatomic abnormalities of target organ
- •Subject underwent transplant or urinary diversion
- •Abnormal kidney function