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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT05224232
Eligibility Criteria:
Inclusion Criteria:
* Unilateral or bilateral trans-femoral amputees;
* Fitted with a rigid carbon insert;
* Any type of stump;
* Any etiology;
* Person able to understand simple commands, to read, write and give informed consent or having the possibility to be accompanied by a trusted person in case of inability to write or read independently;
* Person who has given informed consent;
* Person who has reached the age of 18 years;
* Person affiliated to the french social security system
Exclusion Criteria:
* Fitted with a collar fixed on a socket
* Using SHA for inserting the insert;
* Pregnant or nursing woman;
* Minor;
* Person of full age under legal protection or unable to give consent;
* Person under guardianship or curatorship;
* Person under legal protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05224232
Study Brief:
Protocol Section:
NCT05224232