Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04927234
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 18 years
* Intact healthy skin at the site of geko™ device application.
* Patients that have been listed for forefoot and / or hindfoot surgery
* Patient understands and is willing to participate in the study and can comply with study procedures
* Patient is willing and able to give written informed consent
Exclusion Criteria:
* Pregnant
* Use of any other neuro-modulation device.
* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
* No response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
* Participation in any other clinical study that may interfere with the outcome of either study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04927234
Study Brief:
Protocol Section:
NCT04927234