NCT00587392

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: NDO Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DEVICE	NDO Full-thickness Plicator	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.

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2008-01-07
• Last updated: 2008-01-07

Locations

7 sites across 2 countries: United States, Canada