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Cross Therapy Registry - Edema - US — CTR-Edema-US  

Edema Leg Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04700735
Study type Observational [Patient Registry]
Source Firstkind Ltd
Contact
Status Completed
Phase
Start date June 22, 2021
Completion date November 9, 2023
View Details
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