Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease

Summary

The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux.

Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All patients received a single implant/plication. No repeat plication procedures were performed.

Primary efficacy in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. Secondary efficacy outcomes included post-procedure reduction in anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up assessments were completed at 1, 3, 6 and 12 months post treatment.

Conditions

• GERD

Interventions

DEVICE

NDO Full-thickness Plicator

The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument.

Sponsors & Collaborators

• NDO Surgical, Inc.

  lead INDUSTRY

Principal Investigators

• Douglas Pleskow, MD · Beth Israel Deaconess Medical Center, Boston MA

• Richard Rothstein, MD · Dartmouth Hitchcock Medical Center, Lebanon, NH

• Simon Lo, MD · Cedars Sinai Medical Center, Los Angeles, CA

• Robert Hawes, MD · Medical University of South Carolina

• Richard Kozarek, MD · Virginia Mason Medical Center, Seattle, WA

• Gregory Haber, MD · St. Michael's Hospital, Toronto, Ontario, Canada

• Christopher Gostout, MD · Mayo Clinic, Rochester, MN

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-08-31

Primary Completion

2003-05-31

Completion

2003-05-31

Countries

• United States
• Canada

Study Locations