Chronic SinusitisFRONTIERNCT02880514
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
A study testing PROPEL Mini Sinus Implant and Balloon Sinus Dilation Alone in people with Chronic Sinusitis, run by Intersect ENT at 9 sites in United States.
Trial summary
A randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- PROPEL Mini Sinus Implant and Balloon Sinus Dilation Alone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2016to Jun 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, 87109
ENT of Georgia
Atlanta, Georgia, 30342
ENT Assoicates of South Florida
Boca Raton, Florida, 33487
Associated Surgical Specialists
Covington, Louisiana, 70433
Ohio Sinus Institute
Dublin, Ohio, 43016
St. Luke's ENT Specialists
Kansas City, Missouri, 64111
Advanced ENT and Allergy
Louisville, Kentucky, 40207
Madison ENT
New York, New York, 10016
Sacramento ENT
Sacramento, California, 95815
About this study
Official title: A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
A randomized controlled trial
Read the 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
- Being tested
- PROPEL Mini Sinus Implant, Balloon Sinus Dilation Alone
- Keywords
- Frontal Sinus, Balloon Dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROPEL Mini Sinus ImplantDevice
Also called PROPEL Mini
Sinus implant with 370 mcg of mometasone furoate released over 30 days
Balloon Sinus Dilation AloneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Balloon Sinus Dilation Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (1)
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)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacey Silvers, Principal investigator, Madison ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880514
- Sponsor's protocol ID
- P500-0616
- Acronym
- FRONTIER
- Status last verified
- Nov 2018
- First submitted
- 18 Aug 2016
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No