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Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)

NCT03358329 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-27

Study results available
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Summary

The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.

Conditions

  • Chronic Sinusitis
  • Nasal Polyposis

Interventions

COMBINATION_PRODUCT

S8 Sinus Implant

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Peter Manes, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2019-01-17
Completion
2019-01-17
FDA Drug
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 NCT03358329 on ClinicalTrials.gov