Sensorised Surgical Gloves for Neuroendovascular Procedures

NHS Lothian

Status: Begins enrollment this month

Conditions: Force Sensing Surgical Gloves; Endovascular Procedures

Treatments: Device: Sensorised surgical gloves; Device: Computer vision

Study type: Interventional

Funder types: Other

Identifiers

NCT07372638

IRAS Project ID 331897 (Other Identifier)

REC No. 25/NS/0083 (Other Identifier)

R&D No. 2025/0166

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

- Experienced neurointerventionist or doctor in training.

Exclusion criteria

- No training in use of medical ionising radiation.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Simulated FD procedure

Experimental group

Treatment:

Device: Computer vision

Device: Sensorised surgical gloves