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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT01033357
Eligibility Criteria:
Inclusion Criteria: To be considered for enrollment, subjects must:
* have been randomized in protocol 012-VWAV06;
* have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
* be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
* allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.
Exclusion Criteria:
* Subjects who withdrew or were withdrawn from study 012-VWAV06.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01033357
Study Brief:
Protocol Section:
NCT01033357