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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00586859
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years of age or older.
* History of heartburn or regurgitation for at least 6 months.
* Esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
* pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH\<4.0 \> 4.5% or a DeMeester composite score \> 14.7).
* Symptoms requiring daily PPI therapy.
* GERD-HRQL scores must be \> 15 while Off Medication and Off Medication scores must be \> 6 points higher than On-Medication scores.
* Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
* Subject agrees to participate and signs consent form.
Exclusion Criteria:
* Patient is pregnant.
* Patient has hiatal hernia \> 3 cm.
* Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (\>1 per week) or gas/bloat.
* Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
* Barrett's esophagus with dysplasia.
* Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
* Active medical condition that would preclude the subject from finishing this study.
* Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
* Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
* Presence of esophageal or gastric varices.
* Esophageal dysmotility as determined by manometry studies.
* Esophageal stricture.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00586859
Study Brief:
Protocol Section:
NCT00586859