Registry Study of the NDO Surgical Plicator for the Treatment of GERD

Stopped early · Not applicable

Conditions studied: GERD

In brief

The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed. This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.

Key facts

Study ID

NCT00597792

Run by

NDO Surgical, Inc.

People needed

131

Starts

2004-08-01

Expected to finish

2007-11-01

Last updated by the study team

2008-05-30

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Center of Central Georgia — Macon, Georgia, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Northside Gastroenterology, Inc. — Indianapolis, Indiana, United States
• Lenox Hill Hospital — New York, New York, United States
• Stony brook University Medical Center — Stony Brook, New York, United States
• Nashville Medical Research and the Maria Nathanson Center of Excellence — Nashville, Tennessee, United States
• Digestive Associates of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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