At a glance
ClinicalIndex Comparison RecordN/ACompleted· 75 enrolled
Drug / intervention
Drug-Coated Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The ASCEND Study: A Clinical Evaluation of the UP Drug-Coated Device in Patients With Chronic Rhinosinusitis
In Brief
A clinical study evaluating Drug-Coated Device and Control Device for Chronic Rhinosinusitis (Diagnosis). Completed, enrolled 75 participants across 1 site.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis (Diagnosis)
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJul 2018
Primary CompletionDec 2019
Study CompletionDec 2020
TodayJul 2026
First PostedJul 26, 2018
Enrollment StartJun 12, 2018
Primary CompletionDec 15, 2019
Study CompletionDec 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.9 years ago
Interventions
Drug-Coated Devicedevice
3000 mcg mometasone furoate-coated sinus dilation device
Control Devicedevice
Sinus dilation device without drug