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:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT06700668
Eligibility Criteria:
Inclusion Criteria:
* Male or Female age 22-65.
* The patient must have a unilateral transfemoral amputation .
* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
* The patient must have adequate socket to support the device.
Exclusion Criteria:
* Women who are pregnant.
* Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \>40, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT06700668
Study Brief:
Protocol Section:
NCT06700668