Status:
COMPLETED
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Kidney Transplant
Kidney Pancreas Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical out...
Detailed Description
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standar...
Eligibility Criteria
Inclusion
- Male or female
- At least 18 years old
- Undergoing kidney or kidney pancreas transplant surgery as the recipient
- Able and willing to provide written informed consent
- Absence of known peripheral vascular disease
- Body Mass Index of between 18 and 34
- Leg circumference at site of geko™ device placement is 24" or less
Exclusion
- History of deep vein thrombosis
- Temporary or permanent cardiac pacing
- Patient is pregnant
- Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
- Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
- Previous leg(s) amputation
- Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
- History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
- BMI index \>36
- Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
- History of implantable brain or other stimulator
- Patients who can not tolerate the stimulation from the GEKO device
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01860820
Start Date
June 1 2015
End Date
December 1 2019
Last Update
October 25 2021
Active Locations (1)
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1
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5