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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care with geko™ T3 device | No Intervention | Current geko™ device incorporating hydrogel adhesive designated KM10T | |
| geko™ X-T3 | Active Comparator | Next generation geko™ device incorporating new hydrogel adhesive designated KM40C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| or geko™ X-T3 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indira Natarajan, FRCP | University Hospitals of North Midlands NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | ST4 6QG | United Kingdom |
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| Label | URL |
|---|---|
| Device official website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Geko™ T3 Device | Current geko™ device incorporating hydrogel adhesive designated KM10T |
| FG001 | Geko™ X-T3 Device | Next generation geko™ device incorporating new hydrogel adhesive designated KM40C |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Geko™ T3 Device | Current geko™ device incorporating hydrogel adhesive designated KM10T |
| BG001 | Geko™ X-T3 Device | Next generation geko™ device incorporating new hydrogel adhesive designated KM40C |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | 10 days |
|
Maximum of 10 days from trial inclusion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Geko™ T3 Device | Current geko™ device incorporating hydrogel adhesive designated KM10T |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash at site of geko™ device application | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kieron Day | Firstkind Ltd | +44 (0) 1494 572040 | kieron.day@firstkindmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2020 | Apr 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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A prospective, non-blinded service evaluation of two sequential groups of patients carried out in two phases.
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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 | Not Posted | 10 days | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Geko™ X-T3 Device | Next generation geko™ device incorporating new hydrogel adhesive designated KM40C | 0 | 20 | 0 | 20 | 1 | 20 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |