Sensorised Surgical Gloves for Neuroendovascular Procedures

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endovascular Procedures; Force Sensing Surgical Gloves
• Intervention / Treatment: Device: Sensorised surgical gloves; Device: Computer vision

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan J Downer, MRCP FRCR; Phone Number: +44 131 312 0858; Email: jonny.downer@nhs.scot

Study Locations

• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom
      • Royal Infirmary of Edinburgh
      • Contact: Jonathan J Downer, MRCP FRCR; Phone Number: 0131 312 0858; Email: jonny.downer@nhs.scot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Experienced neurointerventionist or doctor in training.

Exclusion Criteria:

- No training in use of medical ionising radiation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simulated FD procedure	Device: Sensorised surgical gloves; Force sensing surgical gloves; Device: Computer vision; Data collection to investigate potential for computer vision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Force detection from sensorised surgical gloves	Force (newtons) during flow diverter placement in a cerebral aneurysm model	Intra procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective structured assessment of technical skill (OSATS)	OSATS to evaluate task performance	Intra procedural

Collaborators and Investigators

• Sponsor: NHS Lothian
• Investigators: Principal Investigator: Jonathan J Downer, MRCP FRCR, NHS Lothian

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: R&D No. 2025/0166; REC No. 25/NS/0083 (Other Identifier: North of Scotland Research Ethics Committee (1)); IRAS Project ID 331897 (Other Identifier: NHS Health Research Authority)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No