A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD

NDO Surgical

Status

Terminated

Conditions

Gastroesophageal Reflux Disease (GERD)

Treatments

Device: Sham Control

Device: NDO Full-thickness Plicator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00575822

135-01885

Details and patient eligibility

About

The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.

Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.

Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients 18 years or older with a history of heartburn or regurgitation symptoms requiring daily PPI therapy were recruited.

Inclusion Criteria:

GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
Pathologic esophageal acid exposure, defined as pH<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score > 14.7
Lower esophageal resting pressure of at least 5mmHg; and
Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).

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.