N/A
N=75
A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)
Chronic Rhinosinusitis (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT03599271 ↗Enrolled (actual)
75
Serious AEs
1.3%
Results posted
Apr 2021
Primary outcome: Primary: Randomized Cohort: Difference in Patency Grade of FSO — 1.6; 1.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Drug-Coated Device (Device); Control Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intersect ENT
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Randomized Cohort: Difference in Patency Grade of FSO |
1.6; 1.5 | — |
| PRIMARY The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at Baseline |
10 | — |
| SECONDARY Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter |
2.8; 2.6; 2.2; 2.1 | — |
| SECONDARY PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter |
1.2; 3.3; 4.1; 3.3; 2.4; 2.6 | — |
| SECONDARY PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter |
1.1; 2.9; 3.2; 3.1; 2.1; 2.2 | — |
| SECONDARY PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22) |
45.0; 21.2; 27.6 | — |
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)
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.
Data sourced from ClinicalTrials.gov (NCT03599271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.