← Back to Search

Steroid Treatments for Chronic Sinusitis with Nasal Polyps

Phase 2 & 3
Waitlist Available
Led By Marina Boruk, MD
Research Sponsored by Marina Boruk
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of nasal polyposis and desiring surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial will compare the effectiveness of two treatments for post-operative sinus surgery recovery. One is an FDA approved steroid eluting implant, the other is carboxymethylcellulose foam (CMC) combined with triamcinolone acetonide (a steroid). Anticipated sample size is 30. This is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each

Who is the study for?
This trial is for individuals planning to undergo surgery for nasal polyps and chronic sinusitis, who can consent and commit to the study duration. It excludes those with steroid intolerance, incomplete pre-op regimens, oral steroid dependence, immune deficiencies, or pregnancy/breastfeeding; also excluded are those with narrow angle glaucoma or cataracts.Check my eligibility
What is being tested?
The study tests if CMC foam with triamcinolone (a steroid) is as effective and more comfortable than an FDA-approved Propel Stent after sinus surgery. Each patient will have one treatment in each nostril and be monitored through surveys and nasal cavity pictures over a 90-day period.See study design
What are the potential side effects?
Potential side effects may include discomfort from the treatments themselves, possible reactions to steroids like increased pressure in the eye (glaucoma), cataract formation, or reduced ability of the body's immune system to fight infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have nasal polyps and want surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Perioperative Sinus Endoscopy Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Triamcinolone-impregnated CMC foamExperimental Treatment1 Intervention
Applied to one nostril at end of case through randomization. Experimental drug is triamcinolone-acetonide 40mg/mL. 2mL will be combined with 5mL sterile water and mixed with carboxymethylcellulose foam and placed in the nares at the conclusion of the surgery. This will only be applied once and will remain in the nares until it dissolves or 7 days.
Group II: Steroid-eluting implant (Propel)Active Control1 Intervention
Mometasone furoate implant. 370ug of mometasone furoate with each application. One application to be used at the conclusion of surgery and left in place for 1 month or less depending on if it requires removal during office debridement.

Find a Location

Who is running the clinical trial?

Marina BorukLead Sponsor
State University of New York - Downstate Medical CenterOTHER
65 Previous Clinical Trials
12,521 Total Patients Enrolled
Marina Boruk, MDPrincipal Investigator - SUNY Downstate Med Ctr
Kings County Hospital Center, New York Methodist Hospital, SUNY Downstate Medical Center
Medical School - State University of New York, Downstate Medical Center, Doctor of Medicine
State University of New York, Downstate Medical Center, Residency in Otolaryngology

Media Library

Triamcinolone-impregnated CMC foam Clinical Trial Eligibility Overview. Trial Name: NCT03607175 — Phase 2 & 3
Nasal Polyps Research Study Groups: Steroid-eluting implant (Propel), Triamcinolone-impregnated CMC foam
Nasal Polyps Clinical Trial 2023: Triamcinolone-impregnated CMC foam Highlights & Side Effects. Trial Name: NCT03607175 — Phase 2 & 3
Triamcinolone-impregnated CMC foam 2023 Treatment Timeline for Medical Study. Trial Name: NCT03607175 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available spots in this clinical trial for new participants?

"The latest information from clinicaltrials.gov shows that this research is still enrolling patients. The trial was originally advertised on July 18th, 2018 and had a September 24th, 2021 update."

Answered by AI

What medical conditions can be treated by Triamcinolone-impregnated CMC foam?

"Triamcinolone-impregnated CMC foam can be used to treat ulcerative colitis, hand conditions, and certain brain disorders."

Answered by AI

Are there other examples of using Triamcinolone-infused CMC foam to treat patients?

"Currently, there are 48 ongoing clinical trials studying the effects of Triamcinolone-impregnated CMC foam. Out of those active studies, 9 have progressed to Phase 3 testing. Many of the trials for this medication are based in Columbia, Missouri; however, there are a total of 82 locations running these sorts of tests."

Answered by AI

Does the age limit for this research extend below 65 years old?

"This clinical trial requires that patients be between 18-80 years old, with 10 studies for those under 18 and 98 for seniors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis
Marina Boruk 2023. "Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03607175.
~20 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top