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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT03886961
Eligibility Criteria:
Inclusion Criteria:
* Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
* 13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation
* Patient must be willing and able to provide informed consent
* Understands the clinical study requirements and is able to comply with follow-up schedule
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)
* Previous head or neck surgery / radiation
* Carotid artery disease, thyroid disease, or history of cerebral vascular disease
* Nasopharyngeal cancer
* Suspected esophageal cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03886961
Study Brief:
Protocol Section:
NCT03886961