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A Prospective, Randomized, Double-Blind, Multi-Center Trial to Assess the Safety and Efficacy of ASCEND Investigational Drug-Coated Balloon for Sinus Dilation

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Trial Profile

A Prospective, Randomized, Double-Blind, Multi-Center Trial to Assess the Safety and Efficacy of ASCEND Investigational Drug-Coated Balloon for Sinus Dilation

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Oct 2019

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At a glance

  • Drugs Mometasone (Primary)
  • Indications Sinusitis
  • Focus Therapeutic Use
  • Sponsors Intersect ENT

    • Most Recent Events

    • 07 Oct 2019 Status changed to completed, according to an Intersect ENT media release.
    • 07 Oct 2019 Primary endpoint (Intra-patient comparison of frontal sinus patency grade at day 30, as judged by an independent reviewer: superiority of investigational ASCEND product against an uncoated balloon control) has not been met, according to an Intersect ENT media release.
    • 07 Oct 2019 According to an Intersect ENT media release, as the first trial of its kind for this product platform, the company recognized that the outcomes of the ASCEND trial could require further clinical study to support PMA approval with the U.S. Food and Drug Administration.

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