Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results

Study Overview
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Brief Summary
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The purpose of this study was to gather long-term follow-up data on patients treated with the Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at seven U.S. sites. A subset of those patients were subsequently reassessed via symptom questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study was completed and officially closed at the completion of 1-year follow-up. This current study was designed to collect long-term follow-up data on previously plicated subjects all of whom were recruited de novo from the original study population. Study endpoints were prospectively defined. The primary study objectives were to assess: reduction in GERD symptoms through analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and change in overall physical and psychological health as measured by the Short Form Health Survey (SF-36).

Official Title
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Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results

Conditions
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Gastroesophageal Reflux Disease (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 (required prior to original treatment): History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy; esophageal manometry study demonstrating peristaltic amplitude >35mmHg and LES resting pressure >/=5mmHg; Increased esophageal acid exposure demonstrated through a 24-hour pH study. Exclusion Criteria (required prior to original treatment): Erosive esophagitis (Savary-Miller grade III or IV); Barrett's esophagus; Esophageal stricture; Hiatal hernia >2cm; Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat Esophageal or gastric varices; Use of anticoagulants other than for cardiac prophylaxis 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Active NDO Endoscopic Full-thickness Plicator Procedure | Device: NDO Full-thickness Plicator<br>* The NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS). |  | 3 and 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD Medication Use |  | 3 and 5-year | 
| Improvement in overall health as measure by the short form Health Survey (SF-36). |  | 3 and 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease (GERD), Long-term follow-up (LTFU), Endoscopic Full-thickness Plication, Plicator