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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT00597792
Eligibility Criteria:
Inclusion Criteria:
* Subject is suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
* Subject agrees to study participation and signs/dates an informed consent form.
Exclusion Criteria:
* Significant esophageal dysmotility as determined by manometry
* Esophagitis grade III or IV (Savary-Miller)
* Barrett's epithelium
* Hiatus hernia \> 2cm
* Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
* Esophageal or gastric varices
* Previous endoscopic or surgical anti-reflux procedure
* Other esophageal or gastric surgery
* Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00597792
Study Brief:
Protocol Section:
NCT00597792