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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
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
Quality of Life
Time frame: 6, 12, 24, 36, 48, 60 months post-treatment
GERD Medication Use
Time frame: 6, 12, 24, 36, 48, 60 months post-treatment
Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)
Time frame: 6, 12, 24, 36, 48, 60 months post-procedure
Subject satisfaction
Time frame: 6, 12, 24, 36, 48, 60 months post-treatment
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