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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597792
Recruitment Status : Terminated (Sponsoring company ceased business operations)
First Posted : January 18, 2008
Last Update Posted : May 30, 2008
Information provided by:
NDO Surgical, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
GERD Device: NDO Full-thickness Plicator Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Study Start Date : August 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

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.

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment ]

Secondary Outcome Measures :
  1. GERD Medication Use [ Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment ]
  2. 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 ]
  3. Subject satisfaction [ Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00597792

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

Additional Information:
Responsible Party: Bruce Gaumond/Associate Director, Clinical Affairs, NDO Surgical, Inc. Identifier: NCT00597792     History of Changes
Other Study ID Numbers: 135-01762
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by NDO Surgical, Inc.:
Gastroesophageal Reflux Disease (GERD)
Full-thickness Plication