Trials / Completed
CompletedNCT04700735
Cross Therapy Registry - Edema - US
Cross Therapy Registry - Edema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 83 (actual)
- Sponsor
- Firstkind Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | geko Neuromuscular Electro Stimulator (NMES) | Neuromuscular Electro Stimulator (NMES) |
Timeline
- Start date
- 2021-06-22
- Primary completion
- 2023-08-31
- Completion
- 2023-11-09
- First posted
- 2021-01-08
- Last updated
- 2024-03-01
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04700735. Inclusion in this directory is not an endorsement.