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

Study Overview
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Brief Summary
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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)

Detailed Description
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This is a prospective, multicenter study enrolling two consecutive cohorts: PK cohort (N=5): A non-randomized cohort to assess the systemic safety and performance of the UP Drug-Coated Device for in-office bilateral dilation of the FSO (2 inflations in each FSO for a total of 4 inflations per device). Subsequently, the UP Drug-Coated Device may be used to dilate any sphenoid or maxillary sinuses. Randomized cohort (N=70): A randomized, intra-patient controlled, double-blind cohort of 70 subjects to assess the safety and efficacy of the UP Drug-Coated Device used for in-office dilation of the FSO. The FSO randomized to the treatment (Treatment) will undergo dilation using the UP Drug-Coated Device (2 inflations per device) while the contralateral FSO (Control) will be dilated with a UP Control Device (2 inflations per device).

Official Title
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The ASCEND Study: A Clinical Evaluation of the UP Drug-Coated Device in Patients With Chronic Rhinosinusitis

Conditions
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Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Device: Drug-Coated Device
* Device: Control Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of CRS per the 2016, International Consensus Statement on Allergy and Rhinology definition. Bilateral disease in the frontal sinuses (Lund-Mackay score ≥ 1 on each side) on CT scan within 30 days prior to enrollment in the PK cohort and prior to randomization in the randomized cohort. Patient has bilateral obstruction of the frontal recess/FSO due to scarring and/or polypoid edema confirmed on endoscopy (patency grade of 0 or 1 for each FSO). Balloon dilation of the FSO judged to be feasible and medically appropriate. Patient has had prior ESS (> 30 days with a healed mucosa) including bilateral ethmoidectomy (anterior or total) and uncinectomy for better visualization of the FSO. Balloon dilation of the FSO with a 6 mm balloon is judged to be feasible (use light-assisted or image-guided instrument such as a frontal sinus seeker tip to confirm access of each FSO) and medically appropriate. Exclusion Criteria: Expanded amount of ethmoid polyposis (grade > 2 PK cohort, grade ≥ 2 randomized cohort). Complications from prior ESS or balloon dilation procedure (e.g., cerebrospinal fluid leak or injury to the skull base). History of aspirin exacerbated respiratory disease (AERD). Current smokers. History of allergy or intolerance to mometasone furoate. Oral-steroid dependent condition. Evidence of acute rhinosinusitis, invasive fungal sinusitis or another disease or condition expected to compromise survival or ability to complete assessments during the 30-day follow-up period in the PK cohort and druing the 60-day follow-up period in the randomized cohort. Use of parenteral and injected steroids (e.g., Kenalog) 30 days prior to the baseline procedure. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to screening in the PK cohort and prior to baseline in the randomized cohort. Glaucoma or posterior subcapsular cataract.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A PK non-randomized cohort in 5 participants, followed by a randomized, intra-patient controlled double-blind cohort in 70 participants
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-Coated Device<br>Randomized cohort: Drug-Coated Device to dilate randomized frontal sinus ostium. | Device: Drug-Coated Device<br>* 3000 mcg mometasone furoate-coated sinus dilation device<br>|
| Active Comparator: Control Sinus Dilation Device<br>Randomized cohort: Control Device to dilate randomized contralateral frontal sinus ostium. | Device: Control Device<br>* Sinus dilation device without drug<br>|
| Experimental: PK cohort- Drug-Coated Device<br>PK cohort: One Drug-Coated Device to dilate both frontal sinus ostia. | Device: Drug-Coated Device<br>* 3000 mcg mometasone furoate-coated sinus dilation device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomized Cohort: Difference in Patency Grade of FSO | 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) | 30 days | 
| The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter | 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. | 30 days | 
| PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter | 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 to 30 days | 
| PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter | 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 to 30 days | 
| PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22) | 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, Day 14 and Day 30 |