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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT03463395
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of laryngopharyngeal reflux (LPR).
2. Age ≥ 18 years.
3. Reflux Finding Score (RFS) of ≥ 7 and an Reflux Symptom Index (RSI) ≥ 13.
4. Patients should be able to tolerate an endoscopy.
5. Patients must be deemed able to comply with the treatment plan and follow-up schedule.
6. Enrollment on an interventional postoperative study is allowed if study device/agents do not overlap i.e. no other investigational device or medication for the treatment of LPR is permitted during the duration of this study.
7. Patients must provide study-specific informed consent prior to study entry.
Exclusion Criteria:
1. Patient should not be on anticoagulants
2. Currently being treated with another investigational medical device and/or drug.
3. Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP).
4. The patient is female and is of childbearing potential and is not using an acceptable method of birth control or is pregnant or breast-feeding.
5. Previous head or neck surgery or radiation.
6. Carotid artery disease, thyroid disease or history of cerebral vascular disease.
7. Suspected esophageal cancer.
8. Has either a pacemaker or implanted cardioverter defibrillator (ICD).
9. Nasopharyngeal cancer.
10. Previously undergone Nissen Fundoplication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03463395
Study Brief:
Protocol Section:
NCT03463395