GERD Clinical Trial
Official title:
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
The purpose of this study was to evaluate the safety and efficacy of placing multiple
transmural sutures for the treatment of GERD.
A prospective, multi-center, open-label trial was conducted at four centers in Germany to
evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD.
Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL)
questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were
heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD
medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to
provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level
of 0.05.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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