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
281585
Contact name
Indira Natarajan
Contact email
Sponsor organisation
Firstkind Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
The study will look at the stickiness of a new skin adhesive incorporated into a new next generation geko™ device called the geko™ X-T3 and compare it to the adhesive currently used into the geko™ T3 device. Both the geko™ T3 and XT-3 are self adhesive medical devices. They are about the size of a wrist watch and attach to the side of the knee. When switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The study is for people who are in hospital in the Acute Stroke Unit, and who will be receiving daily treatment with the geko™ T3 device in line with UK guidelines as part of their standard acute stroke care and venous thromboembolism prevention. The only difference between the currently used geko™ T3 device and the new geko™ XT-3 device is the adhesive used to attach each device to the skin. Both devices are Œ marked for the purpose they are being used for in the study therefore there will be no differences in the standard of acute stroke care patients receive. By taking part in the study patients will be helping to determine whether the new geko™ XT-3 device will be a suitable replacement for the geko™ T3 device.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
20/SW/0114
Date of REC Opinion
4 Aug 2020
REC opinion
Unfavourable Opinion