Cross Therapy Registry - Edema - US

Study Overview
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Brief Summary
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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.

Detailed Description
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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 clinical data has been collected on the effect of geko™ use in current standard care pathways for edema management on patient outcomes during follow-up of up to twelve months. As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance. 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. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.

Official Title
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Cross Therapy Registry - Edema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™.

Conditions
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Edema Leg

Intervention / Treatment
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* Device: geko Neuromuscular Electro Stimulator (NMES)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: geko Neuromuscular Electro Stimulator (NMES)|Neuromuscular Electro Stimulator (NMES)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety: determine frequency of adverse events (AEs) and serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e. gekoTM vs standard of care (SC). | One year | 
| Performance | Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of routinely collected performance data | Summarize routinely tested and collected performance data, such as patient reported outcome measures and compare to historic and published data i.e. gekoTM vs SC. | One Year | 
| Summary of Health Economic Impact | Summarize health economic impact of gekoTM device on patient outcomes in comparison to SC. | One year |