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

Firstkind

Status: Terminated

Conditions: Edema Leg

Treatments: Device: geko Neuromuscular Electro Stimulator (NMES)

Study type: Observational

Funder types: Industry

Identifiers

NCT04704557

FSK-REG-001-EU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.