Chronic Sinusitis
Conditions
Keywords
Frontal Sinus, Balloon Dilation
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.
Interventions
DEVICEPROPEL Mini Sinus Implant
Sinus implant with 370 mcg of mometasone furoate released over 30 days
PROCEDUREBalloon Sinus Dilation Alone
Sponsors
Intersect ENT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
A total of 50 participants were recruited across 12 clinical sites.
Pre-assignment details
An intra-patient control design was employed where left and right frontal sinuses of each patient were randomized to the treatment or control group after successful completion of in-office balloon dilation.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This study used an intra-patient design with each participant having one sinus side randomized to the treatment group and the other to the control group. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 13.76 |
| Lund-MacKay Frontal Score | 1.2 units on a scale STANDARD_DEVIATION 0.4 |
| Lund-Mackay Total Score | 10.8 units on a scale STANDARD_DEVIATION 3.67 |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants |
| Race/Ethnicity, Customized Race Hispanic | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 49 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 5 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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.
Time frame: Day 30
Population: Outcome analyzed using the intent-to-treat population, which consisted of all randomized subjects and sinuses. Patency grade for 10 sinuses (6 treatment, 4 control) were missing as clinical investigators were unable to view the frontal recess/FSO, reducing the number of evaluable subjects to 44 in the treatment group and 46 in the control group.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| PROPEL Mini Sinus Implant | Patency Rate | 38 sinus sides |
| Balloon Sinus Dilation Alone | Patency Rate | 33 sinus sides |
p-value: 0.0391McNemar
Secondary
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)
Time frame: Day 30
Population: Inflammation score for 7 sinuses (4 treatment, 3 control) were missing as clinical investigators were unable to view the frontal recess/FSO for 3 treatment and 2 control sinuses, and 1 participant with 1 treatment and 1 control sinuses was lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Mini Sinus Implant | Inflammation Score | 43.2 mm | Standard Deviation 32.22 |
| Balloon Sinus Dilation Alone | Inflammation Score | 45.8 mm | Standard Deviation 36.29 |
p-value: 0.68t-test, 2 sided