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

NDO Surgical

Status: Completed

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Device: NDO Full-thickness Plicator

Study type: Observational

Funder types: Industry

Identifiers

NCT00587392

135-01928

Details and patient eligibility

About

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).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

33 participants in 1 patient group

A

Description:

Active NDO Endoscopic Full-thickness Plicator Procedure

Treatment:

Device: NDO Full-thickness Plicator