Efficacy of Adhesive Strength of New Hydrogel Formulation

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: or geko™ X-T3

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • University Hospitals of North Midlands NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care with geko™ T3 device; Current geko™ device incorporating hydrogel adhesive designated KM10T
Active Comparator: geko™ X-T3; Next generation geko™ device incorporating new hydrogel adhesive designated KM40C	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Firstkind Ltd
• Investigators: Principal Investigator: Indira Natarajan, FRCP, University Hospitals of North Midlands NHS Trust

Publications and helpful links

Helpful Links

• Device official website

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FSK-R&D-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No