18 and older, any sex, with Chronic Rhinosinusitis (Diagnosis). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in FSO Patency by Blinded ReviewerPrimary· Day 45
Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
Group
Value
95% CI
PROPEL Contour Sinus Implant
16.54
± 20.83
Balloon Sinus Dilation Alone
12.36
± 16.10
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded ReviewerSecondary· Baseline, Day 45, and Day 180
FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images.
Change from baseline to Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
2.63
± 9.95
Balloon Sinus Dilation Alone
1.15
± 11.09
Change from baseline to Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
3.20
± 10.97
Balloon Sinus Dilation Alone
5.95
± 13.78
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded ReviewerSecondary· Days 45 and 180
FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
383.11
± 437.19
Balloon Sinus Dilation Alone
332.17
± 399.68
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
386.86
± 413.56
Balloon Sinus Dilation Alone
414.30
± 427.56
CT FSO Minimum Diameter by Blinded ReviewerSecondary· Days 45 and 180
CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images.
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
2.38
± 1.94
Balloon Sinus Dilation Alone
1.89
± 1.79
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
2.56
± 2.23
Balloon Sinus Dilation Alone
2.54
± 2.13
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded ReviewerSecondary· Days 45 and 180
CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.
Zinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome.
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
1.23
± 1.22
Balloon Sinus Dilation Alone
1.28
± 1.38
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
1.22
± 1.40
Balloon Sinus Dilation Alone
1.05
± 1.27
Number of Sinus Sides Requiring Post-operative Intervention by Clinical InvestigatorsSecondary· Days 21, 45, 90 and 180
Need for post-operative intervention as determined by clinical investigators per endoscopy.
Day 21
Group
Value
95% CI
PROPEL Contour Sinus Implant
5
Balloon Sinus Dilation Alone
5
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
14
Balloon Sinus Dilation Alone
17
Day 90
Group
Value
95% CI
PROPEL Contour Sinus Implant
12
Balloon Sinus Dilation Alone
16
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
12
Balloon Sinus Dilation Alone
16
CT Cross-sectional Area of FSO by Blinded ReviewerSecondary· Day 180
CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
Group
Value
95% CI
PROPEL Contour Sinus Implant
17.72
± 21.05
Balloon Sinus Dilation Alone
17.81
± 19.96
CT Lund-Mackay Score for the Frontal Sinus by Blinded ReviewerSecondary· Days 45 and 180
CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.
The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.77
± 0.48
Balloon Sinus Dilation Alone
0.77
± 0.56
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.72
± 0.56
Balloon Sinus Dilation Alone
0.67
± 0.55
CT Lund-Mackay Score for the Frontal Sinus by Clinical InvestigatorsSecondary· Days 45 and 180
CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.
The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.59
± 0.59
Balloon Sinus Dilation Alone
0.68
± 0.59
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.53
± 0.64
Balloon Sinus Dilation Alone
0.59
± 0.63
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical InvestigatorsSecondary· Days 21, 45, 90 and 180
Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators.
The adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome.
Day 21
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.37
± 0.63
Balloon Sinus Dilation Alone
0.41
± 0.61
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.30
± 0.62
Balloon Sinus Dilation Alone
0.48
± 0.75
Day 90
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.21
± 0.54
Balloon Sinus Dilation Alone
0.48
± 0.78
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.24
± 0.56
Balloon Sinus Dilation Alone
0.45
± 0.74
Inflammation Score in the Frontal Recess/FSO by Clinical InvestigatorsSecondary· Days 21, 45, 90 and 180
Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators.
Inflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome.
Day 21
Group
Value
95% CI
PROPEL Contour Sinus Implant
25.94
± 29.31
Balloon Sinus Dilation Alone
28.85
± 30.86
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
19.17
± 27.68
Balloon Sinus Dilation Alone
26.67
± 32.16
Day 90
Group
Value
95% CI
PROPEL Contour Sinus Implant
21.97
± 34.10
Balloon Sinus Dilation Alone
28.62
± 33.80
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
17.30
± 31.45
Balloon Sinus Dilation Alone
24.46
± 33.45
Polypoid Edema in the Frontal Recess/FSO by Clinical InvestigatorsSecondary· Days 21, 45, 90 and 180
Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators.
Polypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome.
Day 21
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.63
± 0.82
Balloon Sinus Dilation Alone
0.88
± 1.04
Day 45
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.53
± 0.87
Balloon Sinus Dilation Alone
0.77
± 1.01
Day 90
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.53
± 0.93
Balloon Sinus Dilation Alone
0.80
± 1.02
Day 180
Group
Value
95% CI
PROPEL Contour Sinus Implant
0.52
± 0.85
Balloon Sinus Dilation Alone
0.71
± 0.93
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrollment through Day 180 (end of study).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intersect ENT
Last refreshed: 21 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04858802.