Sensorised Surgical Gloves for Neuroendovascular Procedures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNHS Lothian

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Sensorised surgical gloves

    Device

    Force sensing surgical gloves

  • Computer vision

    Device

    Data collection to investigate potential for computer vision

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Simulated FD procedureExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Force detection from sensorised surgical gloves

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

Time frame
Intra procedural

Secondary outcomes

1

Objective structured assessment of technical skill (OSATS)

OSATS to evaluate task performance

Time frame
Intra procedural

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: