GERD Clinical Trial
Official title:
Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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