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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01647958
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80 years;
2. GERD for \> 1 year;
3. History of daily PPIs for \> 6 months;
4. At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs;
5. Hill grade I and II at gastroesophageal junction;
6. Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing;
7. Willingness to undergo pH testing;
8. Willingness to cooperate with the postoperative diet;
9. Availability for follow-up visits at 6, 12, 24, and 36 months;
10. Willingly and cognitively signed inform consent
Exclusion Criteria:
1. BMI \> 35 Hiatal hernia \> 2c m in axial height and \> 2 cm in greatest transverse dimension;
2. Esophagitis grade C and D;
3. Barrett's esophagus \> 2 cm;
4. Esophageal ulcer;
5. Fixed esophageal stricture or narrowing;
6. Portal hypertension and/or varices;
7. Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
8. Gastroparesis;
9. Coagulation disorders;
10. History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;
11. Pregnancy or plans of pregnancy in the next 12 months;
12. Enrollment in another device or drug study that may confound the results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01647958
Study Brief:
Protocol Section:
NCT01647958