What this study is
Three-dimensional (3D) printing has been an emerging technology with uses in a wide array of fields. This research aims to use 3D printing as a tool to provide personalized education to maximize treatment efficacy based on the patient's individual anatomy. With increased irrigation to the sinuses, we hypothesize there will be improved patient satisfaction and higher quality of life. The outcomes of this research could lead to a new option for patients who live with chronic rhinosinusitis are not candidates for surgery or are interested in less invasive options. The 3D printed nasal replica is not something that would be implanted, rather it is a hand-held device used specifically for participants to better understand their nasal anatomy.
What's being tested
- Irrigation head position
Intervention · OTHER
Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks. The only factor that varied between groups was the head position patients irrigated in.
Study details
- Official title
- 3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.
- Sponsor
- Ohio State University
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps · Chronic Rhinosinusitis Without Nasal Polyps
- Enrolling
- 200 people
- Starts
- 2021-11-01
- Est. completion
- 2027-12-30
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).
You can't join if
- Patients with significant nasal polyps (as determined by a clinician) were excluded upfront due to the unlikeness of irrigation penetration regardless of the head position. Patients with significant atopy, cystic fibrosis, granulomatosis with polyangiitis or other connective tissue disorder, and current pregnancy were also excluded.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Ohio State University Eye and Ear Institue
Columbus, Ohio, United States
- Kai Zhao, PhD · Contact2673032322zhao.1949@osu.edu
- Kai Zhao, PhD · Principal investigator
Recruiting
Study team
Sponsor
Ohio State University
Study ID 2020H0068
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.