Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SI-BONE, Inc.
Age
21–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | LOIS: Long-Term Follow-Up in INSITE/SIFI
