Stroke, Acute
Conditions
Brief 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. 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.
Detailed description
The new skin adhesive incorporated into the next generation geko™ device designated geko™ XT-3 has previously been tested to current international biocompatibility standards (ISO10993) , however the skin adhesive strength of the geko™ X-T3 device compared to that of the current geko™ T3 device has not yet been tested. The reason behind the study is to compare the skin adhesive strength of the two devices in a similar use environment, to determine whether the geko™ XT-3 device will be a suitable replacement for the geko™ T3 device. In total 40 people who are patients in hospital in the Acute Stroke Unit, and who will receive daily treatment with the geko™ T3 device as part of their acute stroke care and venous thromboembolism prevention pathway will be asked if they would like to take part in the study. 20 patients will receive their normal daily treatment with the currently in use geko™ T3 device and 20 patients will receive their normal daily treatment with the new geko™ XT-3 device which has the new skin adhesive. Phase 1 will take place before Phase 2 and each phase will last for a maximum of 10 days or until patients are able to walk independently. Each day during the study and after their standard treatment has been completed, a member of the healthcare team will ask the patient questions about their experience with geko™ device and the answers recorded. The standard acute stroke care patients receive when on the study will not be affected, regardless of which geko™ device they receive and because the study fits into the normal treatment given to these stroke patients whilst in hospital there will be no additional study visits.
Interventions
DEVICEor geko™ X-T3
The geko™ X-T3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. 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.
Sponsors
Firstkind Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A prospective, non-blinded service evaluation of two sequential groups of patients carried out in two phases.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥ 18 years * Currently an in-patient hospitalised for acute stroke * Use of geko™ as a mechanical prophylaxis strategy for venous thromboembolism * Patient understands and is willing to participate in the study and is able to comply with study procedures
Exclusion criteria
* Pregnancy or breast feeding * Use of any neuro-modulation device other than geko™ * Participation in any other clinical study that may interfere with the outcome of either study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM10T. | 10 days | Self reported - how well did the geko™ device stick to the patients leg? Scale 1-5, Lowest score indicates best adhesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 10 days | Reporting of the incidence of adverse events , incidence of serious adverse events, incidence of study treatment related adverse events, and the incidence of device related adverse events |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Geko™ T3 Device Current geko™ device incorporating hydrogel adhesive designated KM10T | 20 |
| Geko™ X-T3 Device Next generation geko™ device incorporating new hydrogel adhesive designated KM40C | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Geko™ T3 Device | Geko™ X-T3 Device | Total |
|---|---|---|---|
| Age, Customized 41-50 | 0 Participants | 3 Participants | 3 Participants |
| Age, Customized 51-60 | 4 Participants | 6 Participants | 10 Participants |
| Age, Customized 61-70 | 4 Participants | 2 Participants | 6 Participants |
| Age, Customized 71-80 | 7 Participants | 7 Participants | 14 Participants |
| Age, Customized >81 | 5 Participants | 2 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM10T.
Self reported - how well did the geko™ device stick to the patients leg? Scale 1-5, Lowest score indicates best adhesion.
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Geko™ T3 Device | Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM10T. | 1.52 score on a scale | Standard Error 0.1 |
| Geko™ X-T3 Device | Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM10T. | 1.23 score on a scale | Standard Error 0.05 |
Secondary
Incidence of Adverse Events
Reporting of the incidence of adverse events , incidence of serious adverse events, incidence of study treatment related adverse events, and the incidence of device related adverse events
Time frame: 10 days