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临床试验/NCT07372638
NCT07372638尚未招募不适用

Sensorised Surgical Gloves for Neuroendovascular Procedures: Preclinical Study in Flow Diverter Placement Using 3D Printed Biorealistic Haptic Simulators

NHS Lothian1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年7月1日最近更新:
干预措施

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

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

Experimental

干预措施: Sensorised surgical gloves (Device)

Simulated FD procedure

Experimental

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)

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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