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

This study has been completed.
Sponsor:
Information provided by:
NDO Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00587522
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention
GERD
Device: NDO Full-thickness Plicator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by NDO Surgical, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD Medication Use [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Improvement in Quality of Life Questionnaires (GERD-HRQL, Gastrointestinal Symptom Rating Scale-GSRS and SF-36) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Esophageal acid exposure [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Esophageal manometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: August 2001
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587522

Locations
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.
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Bruce Gaumond, Associate Director, Clinical Affairs, NDO Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00587522     History of Changes
Other Study ID Numbers: 135-00274
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014