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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT04450628
Eligibility Criteria:
Inclusion Criteria:
* Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
* Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry
* Adult patients ≥18 years
* Elective repairs
Exclusion Criteria:
* Redo hiatal hernia repairs
* Emergent repairs
* Patients with contraindication to surgery or endoscopy
* Patients with esophageal varices
* Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required
* Connective tissue diseases such as scleroderma or lupus
* Diameter measurements less than 5 mm as the EF-325N catheter is not suitable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04450628
Study Brief:
Protocol Section:
NCT04450628