Trials / Terminated
TerminatedNCT04704557
Cross Therapy Registry - Oedema - EU (CTR-Oedema-EU)
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
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Firstkind Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | geko Neuromuscular Electro Stimulator (NMES) | Neuromuscular Electro Stimulator (NMES) |
Timeline
- Start date
- 2021-06-21
- Primary completion
- 2021-11-30
- Completion
- 2021-11-30
- First posted
- 2021-01-11
- Last updated
- 2025-12-04
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04704557. Inclusion in this directory is not an endorsement.