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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT04430218
Eligibility Criteria:
Inclusion Criteria:
* Age 21 or greater
* Acquired upper limb amputation
* Unilateral or bilateral amputation, Above or below elbow
* At least 6 months since time of amputation
* Current user of a myoelectric prosthesis or prescribed to use one
* Viable target nerves in the upper extremity \*
* Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
Exclusion Criteria:
* A contraindication preventing surgery
* Uncontrolled diabetes
* Chronic skin ulcerations
* History of poor wound healing without specific cause
* History of uncontrolled infection without specific cause
* Active infection
* Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
* Inability to speak English
* Expectation that MRI will be required at any point for duration of study or while device is implanted.
* Arthritis in the area of implant
* Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
* Presence of auto immune diseases, or conditions requiring immunosuppression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04430218
Study Brief:
Protocol Section:
NCT04430218