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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01568320
Eligibility Criteria:
Exclusion Criteria:
1. Age \< 18 years;
2. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
4. Unwilling or unable to comply with the follow-up schedule;
5. Inability or refusal to give informed consent;
6. Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
7. Additional medical restrictions as specified in the Clinical Investigation Plan; or
8. Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01568320
Study Brief:
Protocol Section:
NCT01568320