TerminatedNot Applicable

Cross Therapy Registry - Oedema - EU (CTR-Oedema-EU)

Stopped: Issues withh recruitment

Belgium35 participantsStarted 2021-06-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Safety: AEs and SAEs

Timeframe: One year

Performance

Timeframe: One year

Trial details

NCT IDNCT04704557

SponsorFirstkind Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Edema Leg trials