About this trial
Last updated 2 years ago
Study ID
FSK-REG-001-US
Status
Recruiting
Type
Observational [Patient Registry]
Placebo
No
Accepting
18+ Years
All
Trial Timing
Ended a year ago
What is this trial about?
The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and
systematically collect clinical data on all device variants used in standard care pathways
for edema management allowing for the monitoring of patient outcomes during a follow-up
period of up to twelve months.
What are the participation requirements?
Inclusion Criteria
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of gekoTM device application.
- Subjects receiving gekoTM therapy as part of their standard care for edema reduction.
Exclusion Criteria
- Pregnancy or breast feeding.
- Use of any concurrent neuro-modulation device.
- Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
- Bilateral lower limb surgical intervention.
- Unicondylar knee replacement surgical intervention.