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NCT Number: NCT07372638

Sensorised Surgical Gloves for Neuroendovascular Procedures

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Experienced neurointerventionist or doctor in training.

Exclusion criteria

  • No training in use of medical ionising radiation.

Treatment and study plan

Sensorised surgical gloves

Device

Force sensing surgical gloves

Computer vision

Device

Data collection to investigate potential for computer vision

Primary outcomes

  1. Force detection from sensorised surgical gloves

    Time frame: Intra procedural

    Force (newtons) during flow diverter placement in a cerebral aneurysm model

Secondary outcomes

  1. Objective structured assessment of technical skill (OSATS)

    Time frame: Intra procedural

    OSATS to evaluate task performance

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan J Downer, MRCP FRCR

CONTACT

[email protected]

+44 131 312 0858

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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