Registry Study of the NDO Surgical Plicator for the Treatment of GERD

May 29, 2008 updated by: NDO Surgical, Inc.

The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.

This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Macon, Georgia, United States, 31201
        • Medical Center of Central Georgia
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Northside Gastroenterology, Inc.
    • New York
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
      • Stony brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research and the Maria Nathanson Center of Excellence
    • Texas
      • Houston, Texas, United States, 77030
        • Digestive Associates of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
  • Subject agrees to study participation and signs/dates an informed consent form.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Active Plicator Treatment
Device: NDO Full-thickness Plicator
A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment
6, 12, 24, 36, 48, 60 months post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
GERD Medication Use
Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment
6, 12, 24, 36, 48, 60 months post-treatment
Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)
Time Frame: 6, 12, 24, 36, 48, 60 months post-procedure
6, 12, 24, 36, 48, 60 months post-procedure
Subject satisfaction
Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment
6, 12, 24, 36, 48, 60 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NDO Surgical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

May 30, 2008

Last Update Submitted That Met QC Criteria

May 29, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135-01762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe