Cross Therapy Registry - Oedema - EU (CTR-Oedema-EU)

Firstkind Ltd35 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Edema Leg

Interventions

geko Neuromuscular Electro Stimulator (NMES)DEVICE

Neuromuscular Electro Stimulator (NMES)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Safety: AEs and SAEs

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).

Time frame: One year

Performance

Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC.

Time frame: One year

Secondary Outcomes

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.

Time frame: One Year

Summary of Health Economic Impact

Summarize health economic impact of gekoTM device on patient outcomes in comparison to SC.

Time frame: One year

Data from ClinicalTrials.gov

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