An interventional study of geko™ device in Stroke, Acute, Venous Thromboembolism and Deep Vein Thrombosis, sponsored by Firstkind Ltd. Recruiting at 18 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Firstkind Ltd (part of Sky Medical Technology) · Not applicable, Interventional, and Prevention
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Among 372 studies in Stroke with a site in United Kingdom — 60 open to participants now, 80 under way, 8 of them phase 3. Stroke · United Kingdom.
Among the 372 studies in Stroke with a site in United Kingdom, this one is the 56th largest by planned enrollment of the 257 interventional ones that give a count, is one of 22 that started in 2023, is one of 149 with no phase, reaches primary completion later than 21 of the 79 other live ones, and was the 300th registered.
8,268 studies on the registry are indexed under Stroke; 2,062 are open to participants now.
Browse Stroke studies →60 of the 372 studies in Stroke with a site in United Kingdom are open now. Recruiting first, the newest first:
University of Oxford · Sites in United Kingdom
Ages 18+ · Healthy volunteers
Imperial College London · Sites in United Kingdom
Ages 18+
Oxford University Hospitals NHS Trust · Sites in United Kingdom
Ages 18+
Glasgow Caledonian University · Sites in United Kingdom
Ages 16+
Eli Lilly and Company · Sites in United Kingdom, Argentina, Australia and 35 more countries
Ages 50+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
372 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 35 · Phase 3 51 · Phase 4 14
First in 1997; this study’s year is marked. 22 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,200 is above the median of 49 across 6,036 interventional studies indexed under Stroke.
Median enrollment 62 across the 257 interventional studies, 198 across the 115 observational. Of the 238 that completed or were terminated, 51 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
79 of 372 have an industry lead sponsor. The 10 most frequent:
This study is registered under Firstkind Ltd, one of the names counted as Sky Medical Technology. Under that name alone:
Firstkind Ltd is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Sky Medical Technology has 3 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
15 of the studies in Stroke with a site in United Kingdom that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT05298436Guy's and St Thomas' NHS Foundation TrustThe South London Stroke Register: Improving the Lives of Stroke Survivors With Data | 2026-12 |
| NCT06263920Lancashire Teaching Hospitals NHS Foundation TrustNeurofrailty: A Study of Late-onset Epilepsy and Its Associations | 2027-01-12 |
| NCT07484958University of PlymouthCo-designing a Stroke Rehabilitation Trial Toolkit | 2027-01-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 372 studies in Stroke with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This multicentre, randomised geko™ venous thromboembolism (VTE) prevention study will prospectively collect clinical data on VTE occurrences in immobile patients after stroke, who will be randomised, on a 1:1 allocation, to receive either standard of care (Intermittent Pneumatic Compression) or geko™ neuromuscular electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.
Venous thromboembolism (VTE) is a disabling and potentially fatal outcome that may be acquired after having a stroke. The standard treatment to prevent the development of VTE is to give anticoagulation medication. However, this is not recommended in the UK after stroke. Instead the recommended treatment is Intermittent Pneumatic Compression (IPC), where cuffs placed around the lower legs are filled with air to help squeeze the legs and induce blood flow. However, not all patients are able to receive or tolerate IPC treatment. Another treatment which has shown promising results to prevent VTE in immobile patients after stroke, is with a medical device called the geko™ device. The geko™ device is a CE marked medical device which means the manufacturer has checked that the device complies with the essential safety and performance requirements for its' intended use which is to increase blood circulation to help prevent VTE. The aim of this study is to determine if the geko™ device is more effective at preventing VTE in immobile acute stroke patients, than the current IPC standard of care treatment. Following the consent process, stroke patients will be randomised to receive either IPC or geko device. Both devices will be applied until the patient can walk again without help, or for a maximum of 30 days. A compression Doppler exam of the legs will be conducted after 7 days or at discharge if the patient recovers earlier (optional) and after 14 days (mandatory). At 14 days post-randomisation, a patient questionnaire about the comfort of the device, as well as additional health information will be collected. At 30 days after randomisation, additional information about symptomatic DVTs or PEs etc., will be collected from the participant's medical notes. A final follow-up will then be conducted over the phone after 90 days to find out about the patient's recovery, health, mobility and quality of life.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
for the use of the geko™ device:
Contraindications to IPC:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The geko™ device will be applied bilaterally as soon as possible after randomisation and each geko™ device will be used to deliver one 24-hour dose. Devices will be worn continuously and changed every 24 hours. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
Device: geko™ device
Control treatment will be IPC using NHS approved devices as used for standard clinical care. They will be applied to both legs as soon as possible after randomisation. They will not be changed unless damaged or soiled. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier.
Neuromuscular electrical stimulation of the peroneal nerve
Also known as: geko, NMES
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
Determine the number of patients diagnosed to have a VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care. Asymptomatic DVT will be diagnosed using above knee compression Doppler (Compression Duplex Ultrasound) and PE will be diagnosed using ventilation perfusion scan or by computer tomography pulmonary angiogram (CTPA). Compression Dopplers will be conducted any time there is a clinical suspicion of DVT. Above knee compression Dopplers will be conducted at 7 days and 14 days after randomisation, or at patient discharge if patient recovers earlier than 7 d and 14 days post-randomisation.
Time frame: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Device Acceptability
To assess patient tolerability of the geko™ device compared to IPC standard of care, a device acceptability questionnaire will be utilised, which includes questions on discomfort, sleep quality, number of times the device is checked and not in place/not working effectively and number of days the device was worn. Answers to each question will be summarised.
Time frame: At 14 days after randomisation
Device effectiveness
Determine frequency of patient death for any cause, confirmed fatal or non-fatal PE, any (symptomatic or asymptomatic) above knee DVT, any (symptomatic or asymptomatic) popliteal or femoral vein DVT or symptomatic calf vein DVT, and combination of these outcomes. The frequency will be compared between the two groups: geko™ device compared to IPC standard of care.
Time frame: At 30 days after randomisation
Leg pain level using a Numerical Rating Scale (NRS) score
Assessing pain levels using a Numerical Rating Scale (NRS) score: a line from 0 - 10, where 0 means no pain and 10 is the worst possible pain.
Time frame: At 90 days after randomisation
Disability using the modified Rankin score
The modified Rankin score will be used to measure Neurologic Disability. This is a 7-level, clinician reported measure of global disability with possible scores ranging from 0 to 6, where 0 represents "no symptoms at all", 5 represents "severe disability; bedridden, incontinent and requiring constant nursing care and attention" and 6 indicates patient death.
Time frame: At 90 days after randomisation
Health related quality of life using EQ-5D-5L
A validated patient reported outcome measure, the first part of the EQ-5D-5L score is a simple 5-level questionnaire: patient mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each question has five response levels from no problems (Level 1) to extreme problems (Level 5). The second part of the EQ-5D is an EQ VAS to record the patient's self-rated health scored on a 0 - 100 scale representing "the worst..." and "the best health you can imagine", respectively.
Time frame: At 90 days after randomisation
Patient survival
Death from any cause will be recorded, comparing the two groups: geko™ device compared to IPC standard of care.
Time frame: At 90 days after randomisation
Assessment of any symptomatic or asymptomatic DVT or PE
Determine the frequency of VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care.
Time frame: At 90 days after randomisation
Adverse Event Assessments
Incidence of Adverse Events in each group will be recorded.
Time frame: Up to 30 days after randomisation or discharge, whichever comes earlier
NIH Stroke Scale/Score (NIHSS)
The NIHSS scores areas such as level of consciousness, vision, sensation, movement, speech and language with a minimum score of 0 representing no stroke, and 21-42 points representing severe stroke. NIHSS will be compared between the two groups: geko™ device compared to IPC standard of care.
Time frame: At 7 days (optional/if practical) and 14 days after randomisation
Plan to share: No
Started Jul 2023 (actual). Primary completion is estimated for Apr 2025, 21 months after the start.
Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 21 months is below that.
Counting every sponsor, half of 3,261 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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