Healthy Adult ParticipantsNCT07849257
Geko® T3 One vs Two Study
A study testing NMES in people with Healthy Adult Participants, run by Kieron.Day at 1 site in United Kingdom.
Trial summary
The primary objective of this study to assess the haemodynamic effects of unilateral and bilateral geko® T3 stimulation on lower-limb circulation, measured by femoral artery and vein blood flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2025to 16 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- No known history of vascular or neurological conditions affecting the lower limbs.
- Able to read, understand, and communicate in English to ensure informed consent and safe participation in the study.
Who cannot join
- Presence of any condition that contraindicates the use of neuromuscular electrical stimulation (e.g., implanted pacemaker, epilepsy)
- Current or recent injury to the lower limbs that may interfere with stimulation or measurement
- Anatomical variations in the femoral artery or vein, specifically vascular branching outside expected anatomical locations, as identified by ultrasound, which may impair accurate blood flow measurement or device placement
- Currently participating in another interventional or physiological research study, or having done so within the past 30 days
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Haemodynamic Effects of Unilateral vs Bilateral NMES of the Lower Limb Using the Geko® T3 Device in Healthy Volunteers
The primary objective of this study to assess the haemodynamic effects of unilateral and bilateral geko® T3 stimulation on lower-limb circulation, measured by femoral artery and vein blood flow.
Read the detailed description
Prior to baseline measurements, participants will undergo a 5 minute stabilisation period to allow haemodynamic parameters to equilibrate under resting conditions. Following stabilisation, Doppler ultrasound measurements will be taken at the common femoral artery followed by the common femoral vein on both lower limbs to determine Peak Systolic Velocity (PSV) and Volume Flow (mL/min). These baseline assessments will establish reference values for arterial and venous blood flow prior to activation of the geko® T3 device.
Unilateral Stimulation.
The geko® T3 device will be applied to one leg (the geko leg), while the contralateral leg will remain unstimulated. After device activation, a 5 minute stabilisation period will be observed to allow haemodynamic parameters to reach a steady state before measurements begin. Following stabilisation, Doppler ultrasound measurements will be performed first at the femoral artery, then at the femoral vein, on both legs to determine PSV and Volume Flow (mL/min). This data will be used to assess differences in arterial and venous blood flow between the stimulated (geko leg) and non-stimulated (contralateral) limb.
The geko® T3 devices will be applied to both legs simultaneously. After activation, a 5 minute stabilisation period will again be observed to allow haemodynamic parameters to stabilise prior to measurement.
Following stabilisation, Doppler ultrasound assessments will be obtained in the same order, femoral artery first, followed by femoral vein, on both legs to measure PSV and Volume Flow (mL/min). The order of stimulation phases will be fixed, with unilateral stimulation always preceding bilateral stimulation.
A 5 minute rest period will separate the two stimulation phases to allow haemodynamic parameters to return to baseline before commencing the next phase. At each phase (Baseline, Unilateral, and Bilateral), Doppler ultrasound (femoral artery and vein) will be performed on both limbs.
For Doppler assessments, three consecutive recordings at each site (artery and vein), each approximately 20 seconds in duration, will be collected and averaged per phase.
Participants will remain seated throughout all assessments to ensure stable and consistent haemodynamic conditions.
The total participation time for each participant is expected to be approximately 2½ hours, including informed consent, setup, stabilisation and rest periods, all measurements, and debrief.
- Conditions
- Healthy Adult Participants
- Being tested
- NMES
- Keywords
- Blood Circulation, Neuromuscular Electrostimulation, Muscle Contraction, Increase Venous Return
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Exploring Haemodynamic Effects of Unilateral vs Bilateral NMES of the Lower Limb.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Single experimental arm: geko® T3 NMES | Experimental | Each participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit. Receives: Device: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral vein peak systolic velocity during geko® T3 stimulation
Femoral vein peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Measured: During a single study visit of approximately 2.5 hours
Femoral vein volume flow during geko® T3 stimulation
Femoral vein volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Measured: During a single study visit of approximately 2.5 hours
Femoral artery peak systolic velocity during geko® T3 stimulation
Femoral artery peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Measured: During a single study visit of approximately 2.5 hours
Femoral artery volume flow during geko® T3 stimulation
Femoral artery volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Measured: During a single study visit of approximately 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start9 Dec 2025
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, within-subject, comparative study in healthy volunteers. Each participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kieron.Day
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Kieron.Day, Firstkind Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849257
- Sponsor's protocol ID
- FSK-LEG-001
- Other IDs
- FSK-LEG-001
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Haemodynamic Effects of Unilateral vs Bilateral NMES of the Lower Limb Using the Geko® T3 Device in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07849257
- Acronym / sponsor ID
- FSK-LEG-001
- Conditions
- Healthy Adult Participants
- Keywords
- Blood Circulation, Neuromuscular Electrostimulation, Muscle Contraction, Increase Venous Return
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kieron.DayIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 30 Sep 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.
The primary objective of this study to assess the haemodynamic effects of unilateral and bilateral geko® T3 stimulation on lower-limb circulation, measured by femoral artery and vein blood flow.
Detailed description
Prior to baseline measurements, participants will undergo a 5 minute stabilisation period to allow haemodynamic parameters to equilibrate under resting conditions. Following stabilisation, Doppler ultrasound measurements will be taken at the common femoral artery followed by the common femoral vein on both lower limbs to determine Peak Systolic Velocity (PSV) and Volume Flow (mL/min). These baseline assessments will establish reference values for arterial and venous blood flow prior to activation of the geko® T3 device.
Unilateral Stimulation.
The geko® T3 device will be applied to one leg (the geko leg), while the contralateral leg will remain unstimulated. After device activation, a 5 minute stabilisation period will be observed to allow haemodynamic parameters to reach a steady state before measurements begin. Following stabilisation, Doppler ultrasound measurements will be performed first at the femoral artery, then at the femoral vein, on both legs to determine PSV and Volume Flow (mL/min). This data will be used to assess differences in arterial and venous blood flow between the stimulated (geko leg) and non-stimulated (contralateral) limb.
The geko® T3 devices will be applied to both legs simultaneously. After activation, a 5 minute stabilisation period will again be observed to allow haemodynamic parameters to stabilise prior to measurement.
Following stabilisation, Doppler ultrasound assessments will be obtained in the same order, femoral artery first, followed by femoral vein, on both legs to measure PSV and Volume Flow (mL/min). The order of stimulation phases will be fixed, with unilateral stimulation always preceding bilateral stimulation.
A 5 minute rest period will separate the two stimulation phases to allow haemodynamic parameters to return to baseline before commencing the next phase. At each phase (Baseline, Unilateral, and Bilateral), Doppler ultrasound (femoral artery and vein) will be performed on both limbs.
For Doppler assessments, three consecutive recordings at each site (artery and vein), each approximately 20 seconds in duration, will be collected and averaged per phase.
Participants will remain seated throughout all assessments to ensure stable and consistent haemodynamic conditions.
The total participation time for each participant is expected to be approximately 2½ hours, including informed consent, setup, stabilisation and rest periods, all measurements, and debrief.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-centre, within-subject, comparative study in healthy volunteers. Each participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit.
| Arm | Type | Receives |
|---|---|---|
| Experimental : Single experimental arm: geko® T3 NMES | Experimental | Device: NMESEach participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- No known history of vascular or neurological conditions affecting the lower limbs.
- Able to read, understand, and communicate in English to ensure informed consent and safe participation in the study.
Key exclusion criteria (5 listed)
- Presence of any condition that contraindicates the use of neuromuscular electrical stimulation (e.g., implanted pacemaker, epilepsy)
- Current or recent injury to the lower limbs that may interfere with stimulation or measurement
- Anatomical variations in the femoral artery or vein, specifically vascular branching outside expected anatomical locations, as identified by ultrasound, which may impair accurate blood flow measurement or device placement
- Currently participating in another interventional or physiological research study, or having done so within the past 30 days
- Currently pregnant
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 |
|---|---|---|
| NMESExploring Haemodynamic Effects of Unilateral vs Bilateral NMES of the Lower Limb. | Device | Experimental : Single experimental arm: geko® T3 NMES |
Primary outcome
Femoral vein peak systolic velocity during geko® T3 stimulation
Time frame: During a single study visit of approximately 2.5 hours
Femoral vein peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Femoral vein volume flow during geko® T3 stimulation
Time frame: During a single study visit of approximately 2.5 hours
Femoral vein volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Femoral artery peak systolic velocity during geko® T3 stimulation
Time frame: During a single study visit of approximately 2.5 hours
Femoral artery peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Femoral artery volume flow during geko® T3 stimulation
Time frame: During a single study visit of approximately 2.5 hours
Femoral artery volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Available upon request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES in people with Healthy Adult Participants, run by Kieron.Day 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral vein peak systolic velocity during geko® T3 stimulation (time frame: During a single study visit of approximately 2.5 hours). The study lists 4 primary outcomes in all. 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 30 Sep 2026.