Status:
COMPLETED
Cross Therapy Registry - Edema - US
Lead Sponsor:
Firstkind Ltd
Conditions:
Edema Leg
Eligibility:
All Genders
18+ years
Brief Summary
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 manageme...
Detailed Description
The geko™ device has a wide range of clinical applications including the post-operative management of edema. Although many short-term acute studies have been completed using the device, little clinic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 9 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04700735
Start Date
June 22 2021
End Date
November 9 2023
Last Update
March 1 2024
Active Locations (3)
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1
Luminis Health Research Institute
Annapolis, Maryland, United States, 21401
2
Genesee Orthopedics
New Hartford, New York, United States, 13413
3
JIS Orthopedics
New Albany, Ohio, United States, 43054