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 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT00534092
Eligibility Criteria:
Inclusion Criteria:
A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:
1. Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study.
2. Is willing and able to provide Informed Consent
3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.
Exclusion Criteria:
A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:
1. Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
2. Participated in the CAP or COS programs, but the device has been removed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00534092
Study Brief:
Protocol Section:
NCT00534092