Efficacy of adhesive strength of new hydrogel formulation
Research type
Research Study
Full title
Evaluation of the adhesive strength of the geko™ X-T3 neuromuscular stimulator incorporating a new skin adhesive hydrogel formulation designated KM40C
IRAS ID
289498
Contact name
Indira Natarajan
Contact email
Sponsor organisation
Firstkind Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
The geko™ T3 device is a small, self-adhesive, neuromuscular electro-stimulation device which uses an electrically conductive skin adhesive called hydrogel KM10T that sticks the device to the skin below the knee. Electrodes in the hydrogel stimulate a nerve beside the knee which activates calf and foot muscles helping blood return to the heart. The T3 is CE marked, so conforms to EU standards for safety for medical devices and used within the NHS for increasing blood circulation and preventing clots in veins of patients at high risk of clots e.g. stroke patients. KM10T was designed to stick to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. An improved hydrogel named KM40C has been developed with even lower skin irritation but still with good electrode contact. KM40C has already been tested for safety in humans and used as the adhesive in another geko™ called XT-3. The XT-3 is also CE marked for preventing clots so patients receive the same therapy as they would with the T3, the difference being the skin adhesive. KM40C is designed to stick to skin well, but this has not yet been tested in a clinical environment on patients receiving geko™ therapy. The study aims to ensure the XT-3 using the new KM40C will stick to skin as well as, if not better than the T3 using adhesive KM10T currently in use clinically. The study lasts for 10 days and will take place in a hospital Acute Stroke Unit. Participants will be patients who are immobile following acute stroke and receiving geko™ therapy as part of standard care to prevent blood clots. Participants are contributing to the knowledge pool of safety and performance for the geko™ device which may improve treatment for future patients.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
20/SW/0160
Date of REC Opinion
25 Nov 2020
REC opinion
Favourable Opinion