Status:
TERMINATED
Cross Therapy Registry - Oedema - EU (CTR-Oedema-EU)
Lead Sponsor:
Firstkind Ltd
Conditions:
Edema Leg
Eligibility:
All Genders
18+ years
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 ede...
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04704557
Start Date
June 21 2021
End Date
November 30 2021
Last Update
December 4 2025
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1200