A Clinical Evaluation of PROPEL® Contour Sinus Implant
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Intrapatient control in which eligible subjects will receive the PROPEL Contour Sinus Implant (Treatment) on one side, and no implant (Control) on the contralateral side.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 Balloo...
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.
Tracking Information
- NCT #
- NCT04858802
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon