Clinical trial NCT04704557: Cross Therapy Registry - Oedema - EU (CTR-Oedema-EU)
Official title: Cross Therapy Registry - Oedema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™. CTR-Oedema-EU
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Edema Leg
Keywords: Edema Leg
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been identified to receive gekoTM therapy as part of their standard care for oedema reduction.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety: AEs and SAEs
timeFrame: One year
measure: Performance
timeFrame: One year
Secondary outcomes:
measure: Summary of routinely collected performance data
timeFrame: One Year
measure: Summary of Health Economic Impact
timeFrame: One year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
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