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

NCT02880514 | Completed Results

• 1 other identifier: P500-0616
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief Summary

A randomized controlled trial

Conditions

Chronic Sinusitis

Keywords

Frontal Sinus; Balloon Dilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammation Score

  Day 30

Study Arms (2)

PROPEL Mini Sinus Implant

EXPERIMENTAL

Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation

Device: PROPEL Mini Sinus Implant; Procedure: Balloon Sinus Dilation Alone

Balloon Sinus Dilation Alone

ACTIVE COMPARATOR

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

Procedure: Balloon Sinus Dilation Alone

Interventions

PROPEL Mini Sinus Implant DEVICE

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

Also known as: PROPEL Mini

PROPEL Mini Sinus Implant

Balloon Sinus Dilation Alone PROCEDURE

Balloon Sinus Dilation Alone; PROPEL Mini Sinus Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (9)

Sacramento ENT

Sacramento, California, 95815, United States

Location

ENT Assoicates of South Florida

Boca Raton, Florida, 33487, United States

Location

ENT of Georgia

Atlanta, Georgia, 30342, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

Associated Surgical Specialists

Covington, Louisiana, 70433, United States

Location

St. Luke's ENT Specialists

Kansas City, Missouri, 64111, United States

Location

BreatheAmerica of Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

Ohio Sinus Institute

Dublin, Ohio, 43016, United States

Location

Limitations and Caveats

One limitation of this study design is utilizing an intra-patient control. This precludes evaluation of patient-reported outcomes. However, it also minimizes interpatient variability, and the differences in surgical techniques.

Results Point of Contact

• Title: James Stambaugh, Vice President of Clinical & Medical Affairs
• Organization: Intersect ENT, Inc.

jstambaugh@intersectent.com

650-641-2103

Study Officials

• Stacey Silvers

  Madison ENT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 10, 2018
• Results First Posted: December 10, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)