Efficacy of Adhesive Strength of New Hydrogel Formulation

NCT04309110 | Completed Results

• 1 other identifier: FSK-R&D-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Adverse Events

  10 days

Study Arms (2)

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

Device: or geko™ X-T3

Interventions

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.

geko™ X-T3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Links

• Device official website

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Kieron Day
• Organization: Firstkind Ltd

kieron.day@firstkindmedical.com

+44 (0) 1494 572040

Study Officials

• Indira Natarajan, FRCP

  University Hospitals of North Midlands NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, non-blinded service evaluation of two sequential groups of patients carried out in two phases.

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: July 13, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: February 23, 2024
• Results First Posted: February 23, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)