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.
Randomized Cohort: Difference in Patency Grade of FSOPrimary· 30 days
Difference in the patency grade of the FSO between treatment sides at Day 30, as determined by an independent, blinded sinus surgeon based on the centralized video-endoscopy review. Patency of the FSO assessed endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip ("suction tip") and graded on a 5-point scale as follows - 0: Occluded (no opening visible); 1: Significantly stenosed (not occluded, but unable to pass the 3-mm suction tip); 2: Moderately stenosed (able to easily pass the 3-mm suction tip with no additional space around it); 3: Minimally stenosed (able to easi
Group
Value
95% CI
Randomized Cohort - Treatment Arm
1.6
± 1.00
Randomized Cohort - Control Arm
1.5
± 1.07
The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at BaselinePrimary· Baseline
Successful dilation of attempted FSO using the Drug-Coated Device with no unanticipated serious adverse device effects. A successful dilation of the FSO is defined as insertion of the UP Drug-Coated Device into the targeted FSO followed by 2 consecutive, complete inflations of the balloon.
Group
Value
95% CI
PK Cohort-Safety
10
Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) DiameterSecondary· 30 days
The smallest and largest diameters of the FSO determined by an independent, blinded sinus surgeon based on the centralized video-endoscopy review. FSO diameter estimated endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip and reported in mm.
Largest Diameter
Group
Value
95% CI
Randomized Cohort - Treatment Arm
2.8
± 1.86
Randomized Cohort - Control Arm
2.6
± 1.61
Smallest Diameter
Group
Value
95% CI
Randomized Cohort - Treatment Arm
2.2
± 1.44
Randomized Cohort - Control Arm
2.1
± 1.31
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) DiameterSecondary· Baseline to 30 days
The smallest and largest diameters of the FSO are estimated endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip and reported in mm.
Baseline pre-dilation
Group
Value
95% CI
PK Cohort-Safety
1.2
± 0.92
Baseline post-dilation
Group
Value
95% CI
PK Cohort-Safety
3.3
± 2.31
Day 7
Group
Value
95% CI
PK Cohort-Safety
4.1
± 2.02
Day 14
Group
Value
95% CI
PK Cohort-Safety
3.3
± 2.00
Day 21
Group
Value
95% CI
PK Cohort-Safety
2.4
± 2.22
Day 30
Group
Value
95% CI
PK Cohort-Safety
2.6
± 2.12
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) DiameterSecondary· Baseline to 30 days
The smallest and largest diameters of the FSO are estimated endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip and reported in mm.
Baseline pre-dilation
Group
Value
95% CI
PK Cohort-Safety
1.1
± 0.88
Baseline post-dilation
Group
Value
95% CI
PK Cohort-Safety
2.9
± 1.85
Day 7
Group
Value
95% CI
PK Cohort-Safety
3.2
± 1.75
Day 14
Group
Value
95% CI
PK Cohort-Safety
3.1
± 1.91
Day 21
Group
Value
95% CI
PK Cohort-Safety
2.1
± 1.97
Day 30
Group
Value
95% CI
PK Cohort-Safety
2.2
± 1.81
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22)Secondary· Baseline, Day 14 and Day 30
SNOT-22 is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by patient on a 6-point scale as follows: 0: No problem; 1: Very mild problem; 2: Mild or slight problem; 3: Moderate problem; 4: Severe problem; 5: Problem as bad as it can be.
Sum of all 22 questions constitutes the total SNOT-22 score with a maximum total score equal to 110.
Baseline
Group
Value
95% CI
PK Cohort-Safety
45.0
± 10.02
Day 14
Group
Value
95% CI
PK Cohort-Safety
21.2
± 13.9
Day 30
Group
Value
95% CI
PK Cohort-Safety
27.6
± 9.13
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
All Participants From Randomized Cohort
Serious: 1/70 (1%)
Deaths: 0/70
PK Cohort-Safety
Serious: 0/5 (0%)
Deaths: 0/5
Serious adverse events (1 terms)
Reaction
System
All Participants From Rand…
PK Cohort-Safety
Oesophageal Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The objective of the ASCEND Study is to assess the safety, performance, and efficacy of the Intersect ENT UP Drug-Coated Device when used in chronic rhinosinusitis (CRS) patients undergoing balloon dilation of frontal sinus ostia (FSO)
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: 26 May 2021
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/NCT03599271.