StrokeNCT04391257
Study of gekoTM Interaction With Cardiac Pacemakers
A study testing geko™ in people with Stroke and Wound Heal, run by Firstkind Ltd at 2 sites in United Kingdom.
Trial summary
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Wound Heal, Edema Leg
- What is being tested?
- geko™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Dec 2020to 25 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of geko™ device application.
- Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Who cannot join
- Pregnancy or breast feeding.
- Use of any concurrent use of a neuro-modulation device.
- Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
- Participation in any other clinical study that may interfere with the outcome of either study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospital of Wales
Cardiff, CF14 4XW
The Dudley Group NHS Foundation Trust
Dudley, DY1 2HQ
About this study
Official title: A Prospective Trial to Determine if it is Safe to Use the gekoTM Neuromuscular Electrostimulation Device in a Pacemaker Population.
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers.
There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.
Read the detailed description
CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'.
Further, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply.
There is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso.
The geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers.
- Being tested
- geko™
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko™Device
Assess if cardiac pacemakers detect geko™ electrical output pulse.
| Study group | Role | What they receive |
|---|---|---|
| Main | Other | gekoTM neuromuscular electrostimulation device (NMES) briefly used on patients with cardiac pacemakers to check if pacemakers detect the gekoTM electrical pulses as interference. Receives: Device: geko™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period.
Interference with pacemaker function.
Measured: One day - single follow-up.
Secondary outcomes (1)
The secondary endpoints are the incidence of adverse events (AEs), incidence of serious AEs (SAEs), incidence of study treatment related AEs, and the incidence of investigational device related AEs.
Incidence of adverse and serious adverse events.
Measured: One day-single follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start4 Dec 2020
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaheer Yousef, MD, Principal investigator, University Hospital of Wales, Cardiff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391257
- Sponsor's protocol ID
- FSK-CVD-003
- Status last verified
- Aug 2022
- First submitted
- 30 Apr 2020
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Determine if it is Safe to Use the gekoTM Neuromuscular Electrostimulation Device in a Pacemaker Population.
- ClinicalTrials.gov ID
- NCT04391257
- Acronym / sponsor ID
- FSK-CVD-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 18 May 2020 (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 gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers.
There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.
Detailed description
CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'.
Further, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply.
There is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso.
The geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | Other | Device: geko™gekoTM neuromuscular electrostimulation device (NMES) briefly used on patients with cardiac pacemakers to check if pacemakers detect the gekoTM electrical pulses as interference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of geko™ device application.
- Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding.
- Use of any concurrent use of a neuro-modulation device.
- Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
- Participation in any other clinical study that may interfere with the outcome of either study
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 |
|---|---|---|
| geko™Assess if cardiac pacemakers detect geko™ electrical output pulse. | Device | Main |
Primary outcome
The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period.
Time frame: One day - single follow-up.
Interference with pacemaker function.
1 secondary outcome
The secondary endpoints are the incidence of adverse events (AEs), incidence of serious AEs (SAEs), incidence of study treatment related AEs, and the incidence of investigational device related AEs.
Time frame: One day-single follow-up.
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 5 Aug 2022.
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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.
Zaheer Yousef, MD principal investigator
University Hospital of Wales, Cardiff
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko™ in people with Stroke and Wound Heal, run by Firstkind Ltd at 2 sites 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 4 inclusion and 4 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period. (time frame: One day - single follow-up.). 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 5 Aug 2022.