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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02797457
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria common to the 2 groups of patients (allograft group and protheses group):
* Adult aged 18 to 60 years
* Double amputated of both forearms
Transplant eligibility criteria (for allograft group)
* Minimum interval between amputation and graft of three months (no maximal delay)
* Absence of previous psychiatric history contraindicating the graft and psychological maturity, according to two psychiatrists who have evaluated the patient
* No previous history of malignant tumor in remission for less than 5 years
* American Society of Anesthesiology (ASA) score ≤ 2
* New York Heart Association (NYHA) grade ≥ 1
* Creatinine clearance ≥ 60 ml/min/1.73m²
* Absence of badly controlled sever hypertension
Exclusion Criteria:
* Mono amputated patients
* Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02797457
Study Brief:
Protocol Section:
NCT02797457