geko Cross-Therapy REGISTRY-Wound
Research type
Research Study
Full title
An Observational Study for the Post Market Clinical Follow-up of Safety and Patient Outcomes for Patients Undergoing Peroneal Nerve Stimulation by geko™
IRAS ID
301144
Contact name
Agnes Collarte
Contact email
Sponsor organisation
Firstkind Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The geko™ W neuromuscular electrostimulation device is indicated for use to promote wound healing and can be used as part of current standard care given to patientsfor wound management. Although many short-term studies have been completed using the device, little clinical data has been collected on the effect of geko™ W device therapy when used as part of standard care for wound management on patient outcomes during long-term follow-up.\n\nAs the manufacturer of the device, Firstkind Limited, also 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 Registry to provide data to demonstrate patient benefit and regulatory compliance.\n\nThe geko™ Cross Therapy REGISTRY – Wound represents a long-term project to integrate clinical data collected on all geko™ W wound devices (or W device variants) used in standard care pathways for wound management allowing for the monitoring of patient outcomes during longer follow-up periods. \n\nThe clinical data collected for the Registry will form part of the manufacturer’s overall post-market clinical follow-up strategy for the device and post market surveillance to support device safety and performance. \n\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0124
Date of REC Opinion
1 Oct 2021
REC opinion
Favourable Opinion