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

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: NCT00587522
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : January 7, 2008
Information provided by:
NDO Surgical, Inc.

Brief 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.

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

Detailed Description:

The primary objective for this study was to measure the reduction in GERD symptoms as evidenced by analysis of the GERD-HRQL questionnaire at 3-months post-procedure with an objective of achieving a 50% or greater improvement. The trial was powered to detect a 50% reduction in mean GERD-HRQL at 3-months using a one-sided t-test with an α of .05 and a β level of .10, testing versus the equality of means. The calculation referenced above includes the added assumption that the standard deviation will be no more than 20 percent. The null hypothesis stated that the mean percent reduction in GERD symptoms was less than or equal to 50 percent at 3-months versus the alternate hypothesis that it was greater. The device treatment was considered a success if the statistical test rejected the null hypothesis at a one-sided p-value of 0.05 or less. Primary endpoint success was thus related to the statistical conclusion that the mean percent reduction was greater than 50%. A one-sided 95 percent confidence interval was constructed for the percent reduction in GERD symptoms. In order to assess the data with an "Intent to Treat" spirit, the number of patients who achieved a 50% reduction was analyzed as a fraction of the total number of patients who received the treatment.

For secondary endpoint measures, statistical tests for medians were based on a Wilcoxon sign rank test of the percent improvement in a given study measure. This was based on the paired patient data of the pre-treatment scores versus the 6-month scores. The issue of multiple statistical tests of hypothesis being performed on data arising from individual patients was addressed in the following way. The comparison of GERD-HRQL scores was taken as the main results for which no correction of significance level was necessary. To recognize multiple testing using the method of Bonferroni, statistical significance was claimed for the secondary results only if, for a single test, the nominal p-value was <.01. Given that some patients, during the course of the clinical study, were lost to follow-up, all outcomes were examined using the method of last visit carried forward, provided that at least one follow-up visit had been completed. It should be noted that using this method had little impact on the results; as compared to an analysis of the data of just those patients who completed follow-up, excluding those who missed the visit or were lost to follow up. However, this method was employed to account for those patients who were lost to follow-up, with specific consideration to those who had been lost to follow-up due to unsatisfactory treatment effect. Means and standard deviations are reported using the mean (SD) format, medians and interquartile ranges are reported using the median (IQR) format.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease
Study Start Date : August 2001
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
Experimental: A
NDO Full-thickness Plicator Procedure
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.

Primary Outcome Measures :
  1. Percent reduction in GERD symptoms as evidenced by analysis of the GERD-Health Related Quality of Life (HRQL)questionnaire. [ Time Frame: 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. GERD Medication Use [ Time Frame: 3, 6 and 12 months ]
  2. Improvement in Quality of Life Questionnaires (GERD-HRQL, Gastrointestinal Symptom Rating Scale-GSRS and SF-36) [ Time Frame: 3, 6 and 12 months ]
  3. Esophageal acid exposure [ Time Frame: 3 and 6 months ]
  4. Esophageal manometry [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 18 years of age or older.
  • History of heartburn or regurgitation for at least ¬6 months.
  • Esophageal manometry study (conducted within the previous 6 months) demonstrating adequate esophageal peristalsis (defined as a mean amplitude of contraction in the esophageal body of > 35 mm Hg) and a resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
  • 24 hour pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
  • Significant relief of symptoms with PPI therapy.
  • Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
  • Subject agrees to participate and signs consent form.

Exclusion Criteria:

  • Patient is pregnant.
  • Patient has hiatal hernia > 2 cm.
  • Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
  • Esophagitis grades III or IV by Savary criteria.
  • Barrett's esophagus.
  • Patients Baseline Off-Meds GERD-HRQL score <12.
  • Active medical condition that would preclude the subject from finishing this study.
  • Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
  • Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
  • Presence of esophageal or gastric varices.
  • Esophageal dysmotility as determined by manometry studies.
  • Esophageal stricture.

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): NCT00587522

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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M4X1W4
Sponsors and Collaborators
NDO Surgical, Inc.
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Principal Investigator: Douglas Pleskow, MD Beth Israel Deaconess Medical Center, Boston MA
Principal Investigator: Richard Rothstein, MD Dartmouth Hitchcock Medical Center, Lebanon, NH
Principal Investigator: Simon Lo, MD Cedars Sinai Medical Center, Los Angeles, CA
Principal Investigator: Robert Hawes, MD Medical University of South Carolina
Principal Investigator: Richard Kozarek, MD Virginia Mason Medical Center, Seattle, WA
Principal Investigator: Gregory Haber, MD St. Michael's Hospital, Toronto, Ontario, Canada
Principal Investigator: Christopher Gostout, MD Mayo Clinic, Rochester, MN

Publications of Results:
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Responsible Party: Bruce Gaumond, Associate Director, Clinical Affairs, NDO Surgical, Inc. Identifier: NCT00587522     History of Changes
Other Study ID Numbers: 135-00274
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: December 2007

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

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases