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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT02270203
Eligibility Criteria:
Inclusion Criteria:
1. Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
2. Patient has signed study-specific LOIS informed consent form.
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
Exclusion Criteria:
1. Treated with iFuse as a "crossover" in INSITE.
2. Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
3. Patient is a prisoner or a ward of the state.
4. Known or suspected active drug or alcohol abuse.
5. Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
6. Unwilling to perform the long-term follow up requirements of this study.
7. Patient has any condition that could substantially prevent long-term follow-up.
8. Unwilling to return to site at pre-specified study visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT02270203
Study Brief:
Protocol Section:
NCT02270203