Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04391257 |
Other study ID # |
FSK-CVD-003 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 4, 2020 |
Est. completion date |
November 25, 2021 |
Study information
Verified date |
August 2022 |
Source |
Firstkind Ltd |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.