Edema Leg
Conditions
Keywords
Edema Leg
Brief summary
The geko™ Cross Therapy Registry - Oedema - EU (gekoTM CTR - Oedema- EU) 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
The geko™ device has a wide range of clinical applications including the post- operative management of oedema. 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 oedema 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 - Oedema -EU (gekoTM CTR - Oedema - EU) 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.
Interventions
Neuromuscular Electro Stimulator (NMES)
Sponsors
Firstkind Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 oedema 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: AEs and SAEs | One year | 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). |
| Performance | One year | Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of routinely collected performance data | One Year | 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. |
| Summary of Health Economic Impact | One year | Summarize health economic impact of gekoTM device on patient outcomes in comparison to SC. |
Countries
Belgium
Outcome results
None listed