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

NCT ID: NCT02880514

Last Updated: 2018-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-06-30

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.

Conditions

Chronic Sinusitis

Keywords

Frontal Sinus; Balloon Dilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

PROPEL Mini Sinus Implant

Intervention Type: DEVICE

Sinus implant with 370 mcg of mometasone furoate released over 30 days

Balloon Sinus Dilation Alone

Intervention Type: PROCEDURE

Balloon Sinus Dilation Alone

In-office balloon dilation of the contralateral frontal sinus ostia (FSO) without implant placement

Group Type: ACTIVE_COMPARATOR

Balloon Sinus Dilation Alone

Intervention Type: PROCEDURE

Interventions

PROPEL Mini Sinus Implant

Sinus implant with 370 mcg of mometasone furoate released over 30 days

Intervention Type: DEVICE

Balloon Sinus Dilation Alone

Intervention Type: PROCEDURE

Other Intervention Names

PROPEL Mini

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intersect ENT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey Silvers

Role: PRINCIPAL_INVESTIGATOR

Madison ENT

Locations

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

Countries

United States

Other Identifiers

P500-0616

Identifier Type: -

Identifier Source: org_study_id