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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT02552966
Eligibility Criteria:
Inclusion Criteria:
1. Male or female persons age 18-90
2. Patients with LPR symptoms (RSI \>13)
Exclusion Criteria:
1. Pregnant patients per history on initial evaluation.
2. Adults unable to consent in English
3. Patients who are currently imprisoned
4. Patients started on PPI therapy within 4 weeks of study
5. Patients with implants or implant parts that reside in the area where the REZA BAND is applied.
6. Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
7. Patients diagnosed with glaucoma.
8. Patients who had a malignancy of the neck, including neck surgery.
9. Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
10. Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
11. Patients who use nocturnal NIV machines such as CPAP or BiPAP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02552966
Study Brief:
Protocol Section:
NCT02552966