Sensorised Surgical Gloves for Neuroendovascular Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensorised surgical gloves, Computer vision.
- Who it may be relevant to
- Registry conditions: Endovascular Procedures, Force Sensing Surgical Gloves. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sensorised Surgical Gloves for Neuroendovascular Procedures: Preclinical Study in Flow Diverter Placement Using 3D Printed Biorealistic Haptic Simulators
Overview
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.
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.
Interventions
- Device Sensorised surgical gloves
Force sensing surgical gloves - Device Computer vision
Data collection to investigate potential for computer vision
Primary outcome measures
- Force detection from sensorised surgical gloves [Time frame: Intra procedural]
Secondary outcome measures (1)
- Objective structured assessment of technical skill (OSATS) [Time frame: Intra procedural]
Eligibility criteria
Inclusion criteria
\- Experienced neurointerventionist or doctor in training.
Exclusion criteria
\- No training in use of medical ionising radiation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- Royal Infirmary of Edinburgh — Edinburgh
Identifiers
NCT: NCT07372638 · R&D No. 2025/0166 · REC No. 25/NS/0083 · IRAS Project ID 331897