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PROPEL Contour Sinus Implant for Chronic Sinusitis (EXPAND Trial)

N/A
Waitlist Available
Research Sponsored by Intersect ENT
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 21, 45, 90 and 180
Awards & highlights

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)

Eligible Conditions
  • Chronic Sinusitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 21, 45, 90 and 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 21, 45, 90 and 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in FSO Patency by Blinded Reviewer
Secondary study objectives
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
CRS Side-specific Symptom Score by Subject
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PROPEL Contour Sinus ImplantExperimental Treatment1 Intervention
Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.
Group II: Balloon Sinus Dilation AloneActive Control1 Intervention
Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PROPEL Contour Sinus Implant
2021
N/A
~80

Find a Location

Who is running the clinical trial?

Intersect ENTLead Sponsor
13 Previous Clinical Trials
1,020 Total Patients Enrolled
12 Trials studying Chronic Sinusitis
980 Patients Enrolled for Chronic Sinusitis
~18 spots leftby Oct 2025
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