Efficacy of Adhesive Strength of New Hydrogel Formulation

Stroke, Acute Clinical Trial

Official title:

Evaluation of the Adhesive Strength of the Geko™ X-T3 Neuromuscular Stimulator Incorporating a New Skin Adhesive Hydrogel Formulation Designated KM40C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309110
• Other study ID #: FSK-R&D-001
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: November 25, 2021

Study information

• Verified date: July 2023
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• or 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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 days
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	10 days

External Links

•   Device official website