NCT07372638

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

November 19, 2025

Last Update Submit

May 5, 2026

Conditions

Endovascular ProceduresForce Sensing Surgical Gloves

Outcome Measures

Primary Outcomes (1)

  • Force detection from sensorised surgical gloves

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

    Intra procedural

Secondary Outcomes (1)

  • Objective structured assessment of technical skill (OSATS)

    Intra procedural

Study Arms (1)

Simulated FD procedure

EXPERIMENTAL
Device: Sensorised surgical glovesDevice: Computer vision

Interventions

Computer visionDEVICE

Data collection to investigate potential for computer vision

Simulated FD procedure
Sensorised surgical glovesDEVICE

Force sensing surgical gloves

Simulated FD procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Experienced neurointerventionist or doctor in training.

You may not qualify if:

  • \- No training in use of medical ionising radiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Location

Study Officials

  • Jonathan J Downer, MRCP FRCR

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan J Downer, MRCP FRCR

CONTACT

+44 131 312 0858jonny.downer@nhs.scot

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

January 28, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

GB(1)