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A Clinical Evaluation of PROPEL® Contour Sinus Implant

NCT04858802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-04-21

Study results available
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Summary

The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)

Conditions

  • Chronic Rhinosinusitis (Diagnosis)

Interventions

DEVICE

PROPEL Contour Sinus Implant

370 mcg mometasone furoate-coated sinus implant

PROCEDURE

Balloon Sinus Dilation Alone

No PROPEL Contour Sinus Implant

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2022-02-10
Completion
2022-06-20
FDA Device
Yes

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 NCT04858802 on ClinicalTrials.gov