Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT01860820
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01860820
Study Brief:
Protocol Section:
NCT01860820