NCT04858802

A Clinical Evaluation of PROPEL® Contour Sinus Implant

The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)

Detailed description

A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 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.

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
DEVICE	PROPEL Contour Sinus Implant	370 mcg mometasone furoate-coated sinus implant
PROCEDURE	Balloon Sinus Dilation Alone	No PROPEL Contour Sinus Implant

Timeline

• Start date: 2021-05-12
• Primary completion: 2022-02-10
• Completion: 2022-06-20
• First posted: 2021-04-26
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study