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

Study Overview
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Brief Summary
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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.

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

Conditions
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GERD

Intervention / Treatment
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* Device: NDO Full-thickness Plicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Active Plicator Treatment | Device: NDO Full-thickness Plicator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 6, 12, 24, 36, 48, 60 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD Medication Use |  | 6, 12, 24, 36, 48, 60 months post-treatment | 
| Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs) |  | 6, 12, 24, 36, 48, 60 months post-procedure | 
| Subject satisfaction |  | 6, 12, 24, 36, 48, 60 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease (GERD), Plicator, Full-thickness Plication