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

Not Applicable

Completed

• Conditions: Chronic Sinusitis

• 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

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)

Sacramento ENT; 🇺🇸 Sacramento, California, United States

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

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

Advanced ENT and Allergy; 🇺🇸 Louisville, Kentucky, 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

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

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