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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT01942018
Eligibility Criteria:
Inclusion Criteria:
1. Consecutive adult patients (18-70 years of age) with symptomatic dysphagia (dysphagia score ≥2) EGOO that is diagnosed by high resolution manometry.
2. Ability to give informed consent.
Exclusion Criteria:
1. Unable to give informed consent
2. Pregnant or breastfeeding women (all female patients if child-bearing age will undergo urine pregnancy testing prior to endoscopy)
3. Acute gastrointestinal bleeding
4. Coagulopathy defined by prothrombin time \< 50% of control; partial thromboplastin time (PTT) \> 50 sec, or international normalized ratio (INR) \> 1.5), on chronic anticoagulation, or platelet count \<75,000
5. Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
6. Prior esophageal or gastric surgeries
7. Cirrhosis with portal hypertension, varices, and/or ascites
8. Active Esophagitis
9. Hiatal hernia larger than 2cm
10. Barrett's esophagus
11. Eosinophilic esophagitis
12. Esophageal stricture
13. Esophageal malignancy
14. Large esophageal diverticulum
15. Mechanical obstruction to esophageal outflow or infiltrative esophageal or gastric disorders.
16. Prior esophageal Botox injection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01942018
Study Brief:
Protocol Section:
NCT01942018