Trial Outcomes & Findings for A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND) (NCT NCT03599271)

NCT ID: NCT03599271

Last Updated: 2021-05-26

Results Overview

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 easily pass the 3-mm suction tip with additional 1-2 mm space around it); 4: Completely patent (able to easily pass the 3-mm suction tip with additional \>2 mm space around it)

• Recruitment status: COMPLETED
• Target enrollment: 75 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-05-26

Participant Flow

Unit of analysis: frontal sinuses

Participant milestones

Measure	Randomized Cohort Randomized cohort (n=70) used a randomized intra-patient design in which the Drug-Coated Device was used to dilate randomized frontal sinus ostium and Control Device was used to dilate contralateral frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug.	PK Cohort-Safety PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device.
Overall Study STARTED	70 140	5 10
Overall Study Drug-Coated Device	70 70	5 10
Overall Study Control Device	70 70	0 0
Overall Study COMPLETED	70 140	5 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)

Baseline characteristics by cohort

Measure	Randomized Cohort n=70 Participants Randomized cohort (n=70) used a randomized intra-patient desgin which received Drug-Coated Device to dilate randomized frontal sinus ostium and control device in the randomized contralateral frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug.	PK Cohort- Safety n=5 Participants PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device.	Total n=75 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 11.37 • n=5 Participants	61.2 years STANDARD_DEVIATION 10.94 • n=7 Participants	54.9 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	1 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	4 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	5 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	4 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
History of Asthma Yes	33 Participants n=5 Participants	1 Participants n=7 Participants	34 Participants n=5 Participants
History of Asthma No	37 Participants n=5 Participants	4 Participants n=7 Participants	41 Participants n=5 Participants
History of Allergic Rhinitis Yes	61 Participants n=5 Participants	4 Participants n=7 Participants	65 Participants n=5 Participants
History of Allergic Rhinitis No	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
History of Aspirin Intolerance or Allergy Yes	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
History of Aspirin Intolerance or Allergy No	68 Participants n=5 Participants	4 Participants n=7 Participants	72 Participants n=5 Participants
History of Repeated Courses of Corticosteroids Yes	35 Participants n=5 Participants	2 Participants n=7 Participants	37 Participants n=5 Participants
History of Repeated Courses of Corticosteroids No	35 Participants n=5 Participants	3 Participants n=7 Participants	38 Participants n=5 Participants
CT Lund Mackay Score - Total	8.6 Units on a scale STANDARD_DEVIATION 2.94 • n=5 Participants	11.0 Units on a scale STANDARD_DEVIATION 2.92 • n=7 Participants	9.8 Units on a scale STANDARD_DEVIATION 2.9 • n=5 Participants
Number of Prior Endoscopic Sinus Surgery 1	32 Participants n=5 Participants	1 Participants n=7 Participants	33 Participants n=5 Participants
Number of Prior Endoscopic Sinus Surgery 2	20 Participants n=5 Participants	2 Participants n=7 Participants	22 Participants n=5 Participants
Number of Prior Endoscopic Sinus Surgery 3	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Number of Prior Endoscopic Sinus Surgery 4 or more	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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 easily pass the 3-mm suction tip with additional 1-2 mm space around it); 4: Completely patent (able to easily pass the 3-mm suction tip with additional >2 mm space around it)

Outcome measures

Measure	Randomized Cohort - Treatment Arm n=70 Participants Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device	Randomized Cohort - Control Arm n=70 Participants Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium. Control Device: Sinus dilation device without drug
Randomized Cohort: Difference in Patency Grade of FSO	1.6 score on a scale Standard Deviation 1.00	1.5 score on a scale Standard Deviation 1.07

PRIMARY outcome

Timeframe: Baseline

Population: 'Analysis per patient.

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.

Outcome measures

Measure	Randomized Cohort - Treatment Arm n=10 frontal sinus ostia Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device	Randomized Cohort - Control Arm Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium. Control Device: Sinus dilation device without drug
The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at Baseline	10 frontal sinus ostia	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Randomized Cohort - Treatment Arm n=70 Participants Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device	Randomized Cohort - Control Arm n=70 Participants Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium. Control Device: Sinus dilation device without drug
Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter Largest Diameter	2.8 mm Standard Deviation 1.86	2.6 mm Standard Deviation 1.61
Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter Smallest Diameter	2.2 mm Standard Deviation 1.44	2.1 mm Standard Deviation 1.31

SECONDARY outcome

Timeframe: Baseline to 30 days

Population: Analysis per patient.

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.

Outcome measures

Measure	Randomized Cohort - Treatment Arm n=10 frontal sinus ostia Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device	Randomized Cohort - Control Arm Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium. Control Device: Sinus dilation device without drug
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter Baseline pre-dilation	1.2 mm Standard Deviation 0.92	—
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter Baseline post-dilation	3.3 mm Standard Deviation 2.31	—
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter Day 7	4.1 mm Standard Deviation 2.02	—
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter Day 14	3.3 mm Standard Deviation 2.00	—
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter Day 21	2.4 mm Standard Deviation 2.22	—
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter Day 30	2.6 mm Standard Deviation 2.12	—

SECONDARY outcome

Timeframe: Baseline to 30 days

Population: Analysis per patient.

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.

Outcome measures

Measure	Randomized Cohort - Treatment Arm n=10 frontal sinus ostia Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device	Randomized Cohort - Control Arm Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium. Control Device: Sinus dilation device without drug
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter Baseline pre-dilation	1.1 mm Standard Deviation 0.88	—
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter Baseline post-dilation	2.9 mm Standard Deviation 1.85	—
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter Day 7	3.2 mm Standard Deviation 1.75	—
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter Day 14	3.1 mm Standard Deviation 1.91	—
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter Day 21	2.1 mm Standard Deviation 1.97	—
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter Day 30	2.2 mm Standard Deviation 1.81	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Randomized Cohort - Treatment Arm n=5 Participants Randomized cohort (n=70 patients) which received the Drug-Coated Device to dilate randomized frontal sinus ostium. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device	Randomized Cohort - Control Arm Randomized cohort (n=70) which received Control Device to dilate randomized contralateral frontal sinus ostium. Control Device: Sinus dilation device without drug
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22) Baseline	45.0 units on a scale Standard Deviation 10.02	—
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22) Day 14	21.2 units on a scale Standard Deviation 13.9	—
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22) Day 30	27.6 units on a scale Standard Deviation 9.13	—

Adverse Events

All Participants From Randomized Cohort

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

PK Cohort-Safety

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants From Randomized Cohort n=70 participants at risk Randomized cohort (n=70) used a randomized intra-patient design in which the Drug-Coated Device was used to dilate randomized frontal sinus ostium and Control Device was used to dilate contralateral frontal sinus ostium. Each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events are reported per patient in the Randomized Cohort. The adverse events were not collected per intervention. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug.	PK Cohort-Safety n=5 participants at risk PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	1.4% 1/70 • Number of events 1 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	0.00% 0/5 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.

Other adverse events

Measure	All Participants From Randomized Cohort n=70 participants at risk Randomized cohort (n=70) used a randomized intra-patient design in which the Drug-Coated Device was used to dilate randomized frontal sinus ostium and Control Device was used to dilate contralateral frontal sinus ostium. Each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events are reported per patient in the Randomized Cohort. The adverse events were not collected per intervention. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device. Control Device: Sinus dilation device without drug.	PK Cohort-Safety n=5 participants at risk PK cohort (n=5) used a non-randomized design in which one Drug-Coated Device was used to dilate both frontal sinus ostia. Drug-Coated Device: 3000 mcg mometasone furoate-coated sinus dilation device
Infections and infestations Acute Sinusitis	15.7% 11/70 • Number of events 13 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	0.00% 0/5 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/70 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	40.0% 2/5 • Number of events 2 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/70 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	20.0% 1/5 • Number of events 1 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	1.4% 1/70 • Number of events 1 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	20.0% 1/5 • Number of events 1 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.
Infections and infestations Nasopharyngitis	0.00% 0/70 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	20.0% 1/5 • Number of events 1 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.
Infections and infestations Laryngitis	0.00% 0/70 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.	20.0% 1/5 • Number of events 1 • 3 months In the Randomized cohort each patient received the Drug-Coated Device (Treatment Arm) and Control Device (Control Arm) and thus the adverse events were collected per patient and not per intervention. In the PK cohort each patient received the Drug-Coated Device only and the adverse events were collected per patient.

Additional Information

Andrew Campbell PhD, MPH Clinical Affairs Director

Intersect ENT

Phone: 6506412100

Email: acampbell@intersectent.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60