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

NCT03599271 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-05-26

Study results available
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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)

Conditions

  • Chronic Rhinosinusitis (Diagnosis)

Interventions

DEVICE

Drug-Coated Device

3000 mcg mometasone furoate-coated sinus dilation device

DEVICE

Control Device

Sinus dilation device without drug

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2019-12-15
Completion
2020-12-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599271 on ClinicalTrials.gov