Sensorised Surgical Gloves for Neuroendovascular Procedures: Preclinical Study in Flow Diverter Placement Using 3D Printed Biorealistic Haptic Simulators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NHS Lothian
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Force detection from sensorised surgical gloves
研究概览
简要总结
A deeper understanding of the forces required for optimal flow diverter stent deployment could improve procedural safety and shorten the learning curve for new devices. In the past, force sensors have been physically attached to devices in some way. The investigators approach is to incorporate force sensors into the hands of the operator handling the device using sensorised surgical gloves. Participants will be asked to deploy a Flow Diverter (FD) in a biorealistic silicone model while wearing force sensing surgical gloves. The primary objective of the study is to show whether sensorised gloves are capable of meaningful force detection in neurointerventional procedures. The investigators will also explore the potential of developing computer vision technology in neurointervention. The investigators are inviting groups of experts and novices to participate. This will allow the investigators to understand if analysis of glove force outputs can distinguish operator experience.
详细描述
Custom-made conducting melamine foam-based soft piezoresistive sensors will be fabricated and mounted on surgical gloves. Calibration and recording during testing will be made by measuring change in voltage. Participants will be asked to deploy a Pipeline Embolisation Device (Medtronic) in a silicone model. Continuous force recordings will be made, with measurement of the range of forces applied (N) during the procedure. The investigators will compare force recordings for expert and novice operators. Participants will be blinded to the forces they exert. Videos and fluoroscopy images will be recorded and objective structured assessment of technical skills (OSATS) performed.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Experienced neurointerventionist or doctor in training.
排除标准
- •- No training in use of medical ionising radiation.
研究组 & 干预措施
Simulated FD procedure
干预措施: Sensorised surgical gloves (Device)
Simulated FD procedure
干预措施: Computer vision (Device)
结局指标
主要结局
Force detection from sensorised surgical gloves
时间窗: Intra procedural
Force (newtons) during flow diverter placement in a cerebral aneurysm model
次要结局
- Objective structured assessment of technical skill (OSATS)(Intra procedural)
