Overview

This trial is active, not recruiting.

Condition chronic sinusitis
Treatments propel mini or nova sinus implant., sinus surgery only.
Phase phase 3
Sponsor Intersect ENT
Start date September 2014
End date April 2016
Trial size 160 participants
Trial identifier NCT02266810, P500-0514

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.
propel mini or nova sinus implant.
Placement of sinus implant following frontal sinus surgery
(Active Comparator)
This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.
sinus surgery only.
Sinus surgery only, without implant placement

Primary Outcomes

Measure
Reduction in the need for post-operative interventions
time frame: Day 30

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses. - Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery. - Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure. - Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side. - Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created. - Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally) - Septoplasty for access to the ostio-meatal complex is permitted. - ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement. Exclusion Criteria: - Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV) - Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition - Known history of allergy or intolerance to corticosteroids or mometasone furoate - Clinical evidence of acute bacterial sinusitis - Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue) - Active viral illness - Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease - Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period - Currently participating in another clinical trial - History of insulin dependent diabetes mellitus - Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure - Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea - Current ESS including frontal sinus surgery is aborted for any reason. - At least one side is not amenable for implant placement.

Additional Information

Official title 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
Principal investigator Timothy L. Smith, MD, MPH
Description This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each. 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Intersect ENT.