Endovascular ProceduresNCT07372638
Sensorised Surgical Gloves for Neuroendovascular Procedures
A study testing Sensorised surgical gloves and Computer vision in people with Endovascular Procedures and Force Sensing Surgical Gloves, run by NHS Lothian at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endovascular Procedures, Force Sensing Surgical Gloves
- What is being tested?
- Sensorised surgical gloves and Computer vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2027to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Experienced neurointerventionist or doctor in training.
Who cannot join
- No training in use of medical ionising radiation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Scotland
Jonathan J Downer, MRCP FRCR, 0131 312 0858, jonny.downer@nhs.scot
About this study
Official title: 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.
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.
- Being tested
- Sensorised surgical gloves, Computer vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorised surgical glovesDevice
Force sensing surgical gloves
Computer visionDevice
Data collection to investigate potential for computer vision
| Study group | Role | What they receive |
|---|---|---|
| Simulated FD procedure | Experimental | Not described Receives: Device: Sensorised surgical gloves; Device: Computer vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force detection from sensorised surgical gloves
Force (newtons) during flow diverter placement in a cerebral aneurysm model
Measured: Intra procedural
Secondary outcomes (1)
Objective structured assessment of technical skill (OSATS)
OSATS to evaluate task performance
Measured: Intra procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startMar 2027 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jonathan J Downer, MRCP FRCR, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372638
- Sponsor's protocol ID
- R&D No. 2025/0166
- Other IDs
- REC No. 25/NS/0083, IRAS Project ID 331897
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorised Surgical Gloves for Neuroendovascular Procedures: Preclinical Study in Flow Diverter Placement Using 3D Printed Biorealistic Haptic Simulators
- ClinicalTrials.gov ID
- NCT07372638
- Acronym / sponsor ID
- R&D No. 2025/0166
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NHS LothianOther government
- Study start
- Mar 2027 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulated FD procedure | Experimental | Device: Sensorised surgical gloves, Device: Computer vision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Experienced neurointerventionist or doctor in training.
Key exclusion criteria (1 listed)
- No training in use of medical ionising radiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorised surgical glovesForce sensing surgical gloves | Device | Simulated FD procedure |
| Computer visionData collection to investigate potential for computer vision | Device | Simulated FD procedure |
Primary outcome
Force detection from sensorised surgical gloves
Time frame: Intra procedural
Force (newtons) during flow diverter placement in a cerebral aneurysm model
1 secondary outcome
Objective structured assessment of technical skill (OSATS)
Time frame: Intra procedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan J Downer, MRCP FRCR principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorised surgical gloves and Computer vision in people with Endovascular Procedures and Force Sensing Surgical Gloves, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan J Downer, MRCP FRCR (+44 131 312 0858, jonny.downer@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force detection from sensorised surgical gloves (time frame: Intra procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.