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S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

NCT02291549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-08-15

Study results available
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Summary

The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Conditions

  • Chronic Sinusitis
  • Nasal Polyposis

Interventions

DRUG

S8 Sinus Implant

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

DRUG

Mometasone furoate nasal spray

Mometasone furoate nasal spray (200mcg) once daily

PROCEDURE

Sham

In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Robert C Kern, MD · Department of Otolaryngology, Northwestern University, Chicago, IL

  • Jose P. Stolovitzky, MD · ENT of Georgia, Atlanta, GA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-10-31
Completion
2016-10-31
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 NCT02291549 on ClinicalTrials.gov