Cross Therapy Registry - Edema - US

Completed

Conditions studied: Edema Leg

In brief

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.

Key facts

Study ID

NCT04700735

Run by

Firstkind Ltd

People needed

83

Starts

2021-06-22

Expected to finish

2023-11-09

Last updated by the study team

2024-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Luminis Health Research Institute — Annapolis, Maryland, United States
• Genesee Orthopedics — New Hartford, New York, United States
• JIS Orthopedics — New Albany, Ohio, United States

Full record on ClinicalTrials.gov

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