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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT04804150
Eligibility Criteria:
Inclusion Criteria:
* Male or female over 18 years of age.
* Unilateral transtibial amputation for more than 6 months.
* Equipped for more than 3 months with a Seal-in™ liner without the vacuum suspension system.
* Equipped with an ESAR(Energy Storing and Return) foot with the vacuum suspension system
* Patient meeting the criteria of ICF(International Classification of Functioning, Disability and Health) classification d4602 and/or d4608
* Presenting some discomfort in the socket evaluated by a SCS ≤ 7/10
* Absence of severe comorbidity
* Patient with a smartphone and a functional 4G connection
Exclusion Criteria:
* Cognitive impairment that does not allow instructions to be followed
* Have already been equipped with the evaluated vacuum suspension system
* Pregnant women
* Patient subject to a legal protection measure
* Patient not affiliated with social security
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04804150
Study Brief:
Protocol Section:
NCT04804150