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

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

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)

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Device: Drug-Coated Device; Device: Control Device

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Centers for Advanced ENT Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Confirmed diagnosis of CRS per the 2016, "International Consensus Statement on Allergy and Rhinology" definition.
2. 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.
3. 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).
4. Balloon dilation of the FSO judged to be feasible and medically appropriate.
5. 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.
6. 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:

1. Expanded amount of ethmoid polyposis (grade > 2 PK cohort, grade ≥ 2 randomized cohort).
2. Complications from prior ESS or balloon dilation procedure (e.g., cerebrospinal fluid leak or injury to the skull base).
3. History of aspirin exacerbated respiratory disease (AERD).
4. Current smokers.
5. History of allergy or intolerance to mometasone furoate.
6. Oral-steroid dependent condition.
7. 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.
8. Use of parenteral and injected steroids (e.g., Kenalog) 30 days prior to the baseline procedure.
9. 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.
10. Glaucoma or posterior subcapsular cataract.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intersect ENT

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease
• Other Study ID Numbers: P500-0118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No