NCT02266810

Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus

The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.

Detailed description

This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	PROPEL Mini Sinus Implant.	Placement of sinus implant following frontal sinus surgery
PROCEDURE	Sinus Surgery alone	Sinus surgery only, without implant placement
DEVICE	Propel Nova Sinus Implant	Placement of sinus implant following frontal sinus surgery

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-04-01
• Completion: 2016-10-01
• First posted: 2014-10-17
• Last updated: 2018-08-15
• Results posted: 2017-10-06

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study