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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT02366169
Eligibility Criteria:
Inclusion Criteria:
Generally follow the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD
* Positive acid exposure test or endoscopic evidence of esophagitis AND
* Inadequate symptom control or
* Patient preference from surgery over medications or
* Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)
Exclusion Criteria:
* Significant co-morbidity (for example, American Society of Anesthesiologists Grade 3 or higher)
* BMI \>35 or \<20
* No response to proton pump inhibitors
* Grade IV esophagitis
* Hiatal hernia \>3 cm
* Irreducible hernia of any size
* Gastric outlet obstruction
* Short esophagus
* Esophageal diverticula, strictures or varices
* Esophageal motility disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02366169
Study Brief:
Protocol Section:
NCT02366169