Cross Therapy Registry - Edema - US

Completed

• Conditions: Edema Leg

• Registration Number: NCT04700735
• Lead Sponsor: Firstkind Ltd

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-06-22
• Primary Completion: 2023-08-31
• Study Completion: 2023-11-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety	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 Outcome Measures

Name	Time	Method
Summary of Health Economic Impact	One year	Summarize health economic impact of gekoTM device on patient outcomes in comparison to SC.
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.

Trial Locations

Locations (3)

Genesee Orthopedics; 🇺🇸 New Hartford, New York, United States

Luminis Health Research Institute; 🇺🇸 Annapolis, Maryland, United States

JIS Orthopedics; 🇺🇸 New Albany, Ohio, United States