In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia

Chronic Sinusitis Clinical Trial

— FRONTIER  

Official title:

A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880514
• Other study ID #: P500-0616
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2018
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• PROPEL Mini Sinus Implant
Sinus implant with 370 mcg of mometasone furoate released over 30 days

Procedure:
• Balloon Sinus Dilation Alone

Locations

Country	Name	City	State
United States	BreatheAmerica of Albuquerque	Albuquerque	New Mexico
United States	ENT of Georgia	Atlanta	Georgia
United States	ENT Assoicates of South Florida	Boca Raton	Florida
United States	Associated Surgical Specialists	Covington	Louisiana
United States	Ohio Sinus Institute	Dublin	Ohio
United States	St. Luke's ENT Specialists	Kansas City	Missouri
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Madison ENT	New York	New York
United States	Sacramento ENT	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Intersect ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency Rate	Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.	Day 30
Secondary	Inflammation Score	Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)	Day 30