Clinical trial NCT02880514: In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
Official title: A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Keywords: Frontal Sinus
Balloon Dilation
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial

Detailed description: This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.

Eligibility criteria: Inclusion Criteria

* Patient has provided written informed consent using a form approved by the reviewing IRB.
* Patient is 18 years of age or older.
* Patient is willing and able to comply with protocol requirements.
* Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
* CRS diagnosis confirmed by CT scan within 3 months prior to enrollment
* Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side
* Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
* Patient is a candidate for an in-office balloon dilation procedure.
* In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.

Exclusion Criteria:

* Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
* Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
* Known history of allergy or intolerance to corticosteroids or mometasone furoate.
* Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis.
* Active viral illness (e.g., flu, shingles).
* Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure.
* Currently participating in another clinical trial.

Primary outcomes:
measure: Patency Rate
timeFrame: Day 30
Secondary outcomes:
measure: Inflammation Score
timeFrame: Day 30
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
city: Boca Raton
country: United States
facility: ENT Assoicates of South Florida
state: Florida
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Covington
country: United States
facility: Associated Surgical Specialists
state: Louisiana
city: Kansas City
country: United States
facility: St. Luke's ENT Specialists
state: Missouri
city: Albuquerque
country: United States
facility: BreatheAmerica of Albuquerque
state: New Mexico
city: New York
country: United States
facility: Madison ENT
state: New York
city: Dublin
country: United States
facility: Ohio Sinus Institute
state: Ohio
Study officials:
affiliation: Madison ENT
name: Stacey Silvers
role: PRINCIPAL_INVESTIGATOR
References: