TerminatedNot Applicable

Rates of Middle Meatus Synechiae Formation Post ESS

Stopped: Sponsor withdrew funds

10 participantsStarted 2015-04-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age between 18 and 75 years
✓. Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
✓. Patients who need to undergo primary bilateral complete endoscopic sinus surgery
✓. Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments
✓. Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment

Exclusion criteria

✕. Subject is pregnant or breast feeding
✕. Patients with sino-nasal tumors
✕. Patients solely undergoing nasal septal reconstruction
✕. Patients with previous history of endoscopic sinus surgery
✕. Cystic fibrosis or syndromic patients
✕. Patients with autoimmune diseases
✕. Patients who have taken oral steroids less than 30 days prior to surgery
✕. Patients with a history or diagnosis of glaucoma or ocular hypertension

What they're measuring

Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).

Timeframe: 35 to 90days

Trial details

NCT IDNCT03036735

SponsorSteward St. Elizabeth's Medical Center of Boston, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-05

Results submitted2018-04-19

View on ClinicalTrials.gov More Sinusitis trials