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

Not Applicable

Completed

• Conditions: Chronic Sinusitis
• Interventions: Device: PROPEL Mini Sinus Implant; Procedure: Balloon Sinus Dilation Alone

• Registration Number: NCT02880514
• Lead Sponsor: Intersect ENT

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-26
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Results First Submitted: 2018-06-06
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-05
• Last Update Submitted: 2018-11-05
• Results First Posted: 2018-12-10
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PROPEL Mini Sinus Implant	PROPEL Mini Sinus Implant	Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation
Balloon Sinus Dilation Alone	Balloon Sinus Dilation Alone	In-office balloon dilation of the contralateral frontal sinus ostia (FSO) without implant placement
PROPEL Mini Sinus Implant	Balloon Sinus Dilation Alone	Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation

Primary Outcome Measures

Name	Time	Method
Patency Rate	Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Inflammation Score	Day 30	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)

Trial Locations

Locations (9)

ENT Assoicates of South Florida; 🇺🇸 Boca Raton, Florida, United States

Advanced ENT and Allergy; 🇺🇸 Louisville, Kentucky, United States

Ohio Sinus Institute; 🇺🇸 Dublin, Ohio, United States

Madison ENT; 🇺🇸 New York, New York, United States

Sacramento ENT; 🇺🇸 Sacramento, California, United States

ENT of Georgia; 🇺🇸 Atlanta, Georgia, United States

Associated Surgical Specialists; 🇺🇸 Covington, Louisiana, United States

St. Luke's ENT Specialists; 🇺🇸 Kansas City, Missouri, United States

BreatheAmerica of Albuquerque; 🇺🇸 Albuquerque, New Mexico, United States