NCT03599271

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

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
DEVICE	Drug-Coated Device	3000 mcg mometasone furoate-coated sinus dilation device
DEVICE	Control Device	Sinus dilation device without drug

Timeline

• Start date: 2018-06-12
• Primary completion: 2019-12-15
• Completion: 2020-12-09
• First posted: 2018-07-26
• Last updated: 2021-05-26
• Results posted: 2021-04-28

Locations

1 site across 1 country: United States