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Study of gekoTM Interaction With Cardiac Pacemakers

NCT04391257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-08-05

No results posted yet for this study

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 contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers.

There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.

Conditions

  • Stroke
  • Wound Heal
  • Edema Leg
  • Cardiac Pacemaker Electrical Interference

Interventions

DEVICE

geko™

Assess if cardiac pacemakers detect geko™ electrical output pulse.

Sponsors & Collaborators

  • Firstkind Ltd

    lead INDUSTRY

Principal Investigators

  • Zaheer Yousef, MD · University Hospital of Wales, Cardiff

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2021-11-25
Completion
2021-11-25

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391257 on ClinicalTrials.gov