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Safety and Performance of the Steroid-Releasing S8 Sinus Implant

NCT01894503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-07-18

Study results available
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Summary

The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

Conditions

  • Chronic Sinusitis

Interventions

DRUG

S8 Sinus Implant (mometasone furoate, 1350 mcg)

Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Randall Ow, MD · Sacramento ENT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

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 NCT01894503 on ClinicalTrials.gov