Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease

Completed · Not applicable

Conditions studied: GERD

In brief

The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux. Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All patients received a single implant/plication. No repeat plication procedures were performed. Primary efficacy in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. Secondary efficacy outcomes included post-procedure reduction in anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up assessments were completed at 1, 3, 6 and 12 months post treatment.

Key facts

Study ID

NCT00587522

Run by

NDO Surgical, Inc.

People needed

64

Starts

2001-08-01

Expected to finish

2003-05-01

Last updated by the study team

2008-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 adequate esophageal peristalsis (defined as a mean amplitude of contraction in the esophageal body of > 35 mm Hg) and a resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
• 24 hour 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).
• Significant relief of symptoms with PPI therapy.
• 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.

You may not qualify if…

• Patient is pregnant.
• Patient has hiatal hernia > 2 cm.
• Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
• Esophagitis grades III or IV by Savary criteria.
• Barrett's esophagus.
• Patients Baseline Off-Meds GERD-HRQL score <12.
• 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.

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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