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Not yet recruitingNCT07372638Updated Sep 24, 2026

Sensorised Surgical Gloves for Neuroendovascular Procedures

An interventional study of Sensorised surgical gloves and Computer vision in Endovascular Procedures and Force Sensing Surgical Gloves, sponsored by NHS Lothian. Not yet recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by NHS Lothian · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endovascular Procedures
  • Force Sensing Surgical Gloves
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

- Experienced neurointerventionist or doctor in training.

Exclusion criteria

Exclusion Criteria:

- No training in use of medical ionising radiation.

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Simulated FD procedure

    Device: Sensorised surgical gloves · Device: Computer vision

Interventions

  • DeviceSensorised surgical gloves

    Force sensing surgical gloves

  • DeviceComputer vision

    Data collection to investigate potential for computer vision

05

What researchers measure

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

06

Study locations

1 site
  • Royal Infirmary of Edinburgh
    Edinburgh, Scotland, United Kingdom
07

Registry details

Key details

Study ID
NCT07372638
Lead sponsor
NHS Lothian
Responsible party
Sponsor
First posted
Jan 28, 2026
Start date
Mar 2027 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Jonathan J Downer, MRCP FRCR
Contact
jonny.downer@nhs.scot
+44 131 312 0858
Jonathan J Downer, MRCP FRCR
principal investigator · NHS Lothian

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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