Clinical trial NCT02266810: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
Collaborators: name: Advance Research Associates
First posted: 2014-10-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-patient control
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
timeFrame: Day 30
measure: Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
timeFrame: Day 30
Secondary outcomes:
measure: Need for Post-operative Interventions (Propel Mini Cohort)
timeFrame: Day 30
measure: Need for Surgical Interventions (Propel Mini Cohort)
timeFrame: Day 30
measure: Inflammation (Propel Mini Cohort)
timeFrame: Day 30
measure: Occlusion/Restenosis (Propel Mini Cohort)
timeFrame: Day 30
measure: Need for Post-operative Interventions (Propel Nova Cohort)
timeFrame: Day 30
measure: Need for Surgical Interventions (Propel Nova Cohort)
timeFrame: Day 30
measure: Inflammation (Propel Nova Cohort)
timeFrame: Day 30
measure: Occlusion/Restenosis (Propel Nova Cohort)
timeFrame: Day 30
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento Ear, Nose and Throat
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute of Sinus and Allergy Relief
state: California
city: Norwalk
country: United States
facility: The Connecticut Center for Advanced ENT Care
state: Connecticut
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Albany
country: United States
facility: Albany ENT and Allergy
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Norfolk
country: United States
facility: East Virginia Medical School
state: Virginia
Study officials:
affiliation: Oregon Health and Science University
name: Timothy L. Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Amber U. Luong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1.
citation: Luong A, Ow RA, Singh A, Weiss RL, Han JK, Gerencer R, Stolovitzky JP, Stambaugh JW, Raman A. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jan;144(1):28-35. doi: 10.1001/jamaoto.2017.1859. Epub 2017 Nov 2.