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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04704557
Study type Observational [Patient Registry]
Source Firstkind Ltd
Contact
Status Suspended
Phase
Start date June 21, 2021
Completion date February 2025

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