Stroke Clinical Trial
Official title:
A Prospective Trial to Determine if it is Safe to Use the gekoTM Neuromuscular Electrostimulation Device in a Pacemaker Population.
Verified date | August 2022 |
Source | Firstkind Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | November 25, 2021 |
Est. primary completion date | November 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital of Wales | Cardiff | |
United Kingdom | The Dudley Group NHS Foundation Trust | Dudley |
Lead Sponsor | Collaborator |
---|---|
Firstkind Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period. | Interference with pacemaker function. | One day - single follow-up. | |
Secondary | 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. | One day-single follow-up. |
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