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Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

NCT01732536 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-20

Study results available
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Summary

The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Conditions

  • Chronic Sinusitis
  • Nasal Polyps

Interventions

DRUG

S8 Sinus Implant

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

PROCEDURE

Sham procedure

In-office bilateral sham procedure

DRUG

Mometasone furoate nasal spray

Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Keith D Forwith, MD · Advanced ENT and Allergy

  • Joseph K Han, MD · Eastern Virginia Medical School Department of Otolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-11-30
Completion
2014-05-31
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 NCT01732536 on ClinicalTrials.gov