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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT01678157
Eligibility Criteria:
Inclusion Criteria:
* Documented symptomatic paraesophageal hernia.
* Greater than 5 cm hiatal hernia on upper gastrointestinal study.
* Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.
* Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.
* Consenting adult 19 years of age or older
* Must be able to participate in follow-up evaluation.
* Free of cognitive impairment
Exclusion Criteria:
* Children and adolescents (19 years of age or younger).
* Pregnant and breast feeding patients.
* Vulnerable subjects such as pregnant women, children less than 19 years age, and decisionally impaired persons.
* Patients with previous operation of the esophagus or stomach.
* Patients with associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease).
* Patients with emergent operation for acute gastric volvulus.
* Patients with known sensitivity to porcine material.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01678157
Study Brief:
Protocol Section:
NCT01678157