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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02320968
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between the ages of 18 and 65;
* Between 5'4" and 6'2"
* Body Mass Index\<32
* Willing and able to provide written informed consent;
* Understands the clinical study requirements and is able to comply with the follow-up schedule set forth in the protocol;
* Clinically diagnosed with gastroesophageal reflux disease with extra-esophageal symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing);
* Presents with Reflux Symptom Index (RSI) \> 13;
* Undergoing Esophagogastroduodenoscopy (EGD) as part of routine care;
* Undergoing 96-hour pH monitoring via BRAVO capsule as part of routine care.
Exclusion Criteria:
* Currently being treated with another investigational medical device and/or drug;
* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP);
* Female patients who are of child-bearing potential and not using an acceptable method of birth control, or is pregnant or breast-feeding;
* Suspected esophageal cancer;
* Confirmed nasopharyngeal cancer;
* Previously undergone Nissen Fundoplication;
* Hiatal hernia \> 4 cm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02320968
Study Brief:
Protocol Section:
NCT02320968