Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
Gastroesophageal Reflux Disease (GERD), Long-term follow-up (LTFU), Endoscopic Full-thickness Plication, Plicator
Brief summary
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).
Interventions
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.
Sponsors
NDO Surgical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada, United States
Outcome results
None listed