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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT03999502
Eligibility Criteria:
Inclusion Criteria:
* 1\. Subject is 21 - 70 years of age at the time of informed consent 2. Subject has documented symptoms of GERD (heartburn and/or regurgitation) for longer than 12 months, which respond at least partially to proton pump inhibitors (PPIs) 3. Subject is under continuous PPI therapy for at least 6 months 4. Subject has a diagnosis of GERD based on at least 2 of the following criteria:
1. Past demonstration of reflux esophagitis grade A, B or C (LA classification)
2. Abnormal esophageal acid exposure during esophageal pH-impedance monitoring (defined as distal esophageal pH \< 4 for \> 4 % of the monitoring time) performed after at least 7 days off of PPIs
3. Positive symptom association between GERD symptoms and reflux episodes (symptom association probability ≥ 95%) demonstrated at pH-impedance monitoring)
Exclusion Criteria:
* Subjects who meet any of the following exclusion criteria cannot be enrolled in the study:
1. Subject underwent previous surgery involving the gastroesophageal junction, such as a Nissen fundoplication
2. Subject underwent previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
3. Subject has a hiatal hernia larger than 3 cm as determined by endoscopy
4. Subject has history of gastroparesis
5. Subject has any non-GERD esophageal motility disorders that in the opinion of investigator precludes an anti-reflux procedure
6. Subject has history of or known esophageal stricture or significant esophageal anatomic abnormalities (obstructive lesions, etc.)
7. Subject has Barrett's epithelium or any grade of dysplasia
8. Subject has documented history of esophagitis Grade D (LA Classification)
9. Subject has a history of suspected or confirmed esophageal or gastric cancer
10. Subject has esophageal or gastric varices
11. Subject has symptoms of dysphagia more than once per week every week within the last 3 months
12. Subject is unable to tolerate withdrawal from PPI medications
13. Subject has a body mass index (BMI) \> 35 kg/m2
14. Subject has any significant multisystem diseases
15. Subject has an autoimmune or a connective tissue disorder (scleroderma, dematomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2 years
16. Subject has Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c \> 9.5 in the previous 6 months or at screening/baseline
17. Subject has had a significant cerebrovascular event within the last 6 months
18. Female subject of child-bearing potential and is pregnant or nursing, or intends to become pregnant during the trial period, who is not using a reliable form of birth control
19. Subject is currently enrolled in other potentially confounding research
20. Subject has an active infection as determined by the investigator
21. Subject has a history of any malignancy in the last 2 years
22. Subject has a life expectancy less than 3 years
23. Subject has a diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)
24. Subject has any condition that, at the discretion of the investigator or sponsor, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial
25. Subject has a diagnosis of eosinophilic esophagitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03999502
Study Brief:
Protocol Section:
NCT03999502