A Clinical Evaluation of PROPEL Contour Sinus Implant

  • STATUS
    Not Recruiting
  • days left to enroll
    83
  • participants needed
    80
  • sponsor
    Intersect ENT
Updated on 18 April 2022

Summary

The objective of this study is to evaluate the efficacy of PROPEL Contour Sinus Implant placement in the frontal sinus ostia following dilation in patients with chronic rhinosinusitis (CRS)

Description

A prospective, randomized, single-blind (blinded Independent Reviewer), intra-patient controlled, multicenter post-market study with 80 randomized subjects at up to 15 study centers.

After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.

Details
Condition Chronic Rhinosinusitis, Chronic Sinusitis
Treatment PROPEL Contour Sinus Implant, Balloon Sinus Dilation Alone
Clinical Study IdentifierNCT04858802
SponsorIntersect ENT
Last Modified on18 April 2022

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