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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT06348420
Eligibility Criteria:
Inclusion Criteria:
* 18-60 years of age;
* Hiatal hernia ≤ 2 cm;
* Sliding hernia ≤ 2 cm;
* Recurrence of GERD symptoms after cessation of PPIs;
* On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
* Esophagitis (Los Angeles Classification) Grade B, C, or D;
* Hill's flap valve grade ≤ III;
* Observation of distal esophageal pH \< 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;
* Normal or near-normal esophageal motility;
* Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;
* DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;
* Completion of a signed informed consent form.
Exclusion Criteria:
* BMI \> 35 kg/m2;
* ASA \> II;
* Barrett's esophagus;
* Hiatal hernia \> 2 cm;
* Esophagitis (Los Angeles Classification) Grade A or No esophagitis；
* Hill's flap valve grade \> III；
* Peptic ulcer disease;
* Primary esophageal motility disorders such as achalasia;
* Severe gastroparesis;
* History of previous esophageal or gastric surgery, including ARMS or ARMA;
* Uncontrolled systemic diseases;
* Gastric outlet obstruction;
* Pregnancy or planning to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06348420
Study Brief:
Protocol Section:
NCT06348420