Status:
COMPLETED
Study of gekoTM Interaction With Cardiac Pacemakers
Lead Sponsor:
Firstkind Ltd
Conditions:
Stroke
Wound Heal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This ...
Detailed Description
CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'. Furth...
Eligibility Criteria
Inclusion
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of geko™ device application.
- Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion
- Pregnancy or breast feeding.
- Use of any concurrent use of a neuro-modulation device.
- Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
- Participation in any other clinical study that may interfere with the outcome of either study
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04391257
Start Date
December 4 2020
End Date
November 25 2021
Last Update
August 5 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
2
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom, DY1 2HQ