Back to resultsA Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)
Primary Purpose
Chronic Rhinosinusitis (Diagnosis)
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Drug-Coated Device
Control Device
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis)
Eligibility Criteria
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.
Sites / Locations
- Centers for Advanced ENT Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Drug-Coated Device
Control Sinus Dilation Device
PK cohort- Drug-Coated Device
Arm Description
Randomized cohort: Drug-Coated Device to dilate randomized frontal sinus ostium.
Randomized cohort: Control Device to dilate randomized contralateral frontal sinus ostium.
PK cohort: One Drug-Coated Device to dilate both frontal sinus ostia.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03599271
Brief Title
A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)
Official Title
The ASCEND Study: A Clinical Evaluation of the UP Drug-Coated Device in Patients With Chronic Rhinosinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Interventional Study Model
Sequential Assignment
Model Description
A PK non-randomized cohort in 5 participants, followed by a randomized, intra-patient controlled double-blind cohort in 70 participants
Masking
ParticipantOutcomes Assessor
Masking Description
The randomized cohort is double-blinded, which both participants and outcome assessor being masked to treatment assignment
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug-Coated Device
Arm Type
Experimental
Arm Description
Randomized cohort: Drug-Coated Device to dilate randomized frontal sinus ostium.
Arm Title
Control Sinus Dilation Device
Arm Type
Active Comparator
Arm Description
Randomized cohort: Control Device to dilate randomized contralateral frontal sinus ostium.
Arm Title
PK cohort- Drug-Coated Device
Arm Type
Experimental
Arm Description
PK cohort: One Drug-Coated Device to dilate both frontal sinus ostia.
Intervention Type
Device
Intervention Name(s)
Drug-Coated Device
Intervention Description
3000 mcg mometasone furoate-coated sinus dilation device
Intervention Type
Device
Intervention Name(s)
Control Device
Intervention Description
Sinus dilation device without drug
Primary Outcome Measure Information:
Title
Randomized Cohort: Difference in Patency Grade of FSO
Description
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)
Time Frame
30 days
Title
The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at Baseline
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter
Description
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.
Time Frame
30 days
Title
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter
Description
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.
Time Frame
Baseline to 30 days
Title
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter
Description
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.
Time Frame
Baseline to 30 days
Title
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22)
Description
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.
Time Frame
Baseline, Day 14 and Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Centers for Advanced ENT Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)
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