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COVID-19 And Geko Evaluation: The CAGE Study

NCT04651374 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-10

No results posted yet for this study

Summary

The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19.

Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

Conditions

  • Covid19

Interventions

DEVICE

geko T3

The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Tina Mele · Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2022-11-08
Completion
2022-11-08

Countries

  • Canada

Study Locations

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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 NCT04651374 on ClinicalTrials.gov