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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT04253392
Eligibility Criteria:
Inclusion Criteria:
1. Subject is \>or=21 years old
2. Subject with prospective plans for a LINX procedure
3. Subject provides written informed consent
4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)
Exclusion Criteria:
1. Subject who was previously implanted with LINX device
2. Any reason which the Principal Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements (i.e. medical illness and/or limited life expectancy of less than 10 years)
Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT04253392
Study Brief:
Protocol Section:
NCT04253392