CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 160 enrolled
Drug / intervention
PROPEL Mini Sinus Implant. +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02266810
NCT02266810Phase 3Completed

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

Intersect ENT·interventional·Posted Oct 17, 2014·Updated Aug 15, 2018

In Brief

A Phase 3 clinical trial evaluating PROPEL Mini Sinus Implant., Sinus Surgery alone, and 1 other intervention for Chronic Sinusitis. Completed, enrolled 160 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 17, 2014
Enrollment StartSep 1, 2014
Primary CompletionApr 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.7 years ago

Interventions

PROPEL Mini Sinus Implant.device

Placement of sinus implant following frontal sinus surgery

Sinus Surgery aloneprocedure

Sinus surgery only, without implant placement

Propel Nova Sinus Implantdevice

Placement of sinus implant following frontal sinus surgery