Rates of Middle Meatus Synechiae Formation Post ESS

NCT03036735 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-10-19

Study results available
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Summary

The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.

Conditions

  • Sinusitis

Interventions

DEVICE

steroid eluting spacer

The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.

Sponsors & Collaborators

  • SinuSys Corporation

    collaborator INDUSTRY
  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-05
Primary Completion
2016-04-05
Completion
2016-12-31

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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 NCT03036735 on ClinicalTrials.gov