MedTrace Logo

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

NCT02266810 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-08-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Chronic Sinusitis

Interventions

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

Sponsors & Collaborators

  • Advance Research Associates

    collaborator OTHER

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Timothy L. Smith, MD, MPH · Oregon Health and Science University

  • Amber U. Luong, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-04-30
Completion
2016-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266810 on ClinicalTrials.gov