Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD

Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.

A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.

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.