NCT07372638

Sensorised Surgical Gloves for Neuroendovascular Procedures

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NHS Lothian · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endovascular Procedures
• Force Sensing Surgical Gloves

Interventions

Type	Name	Description
DEVICE	Sensorised surgical gloves	Force sensing surgical gloves
DEVICE	Computer vision	Data collection to investigate potential for computer vision

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: United Kingdom