RecruitingNot ApplicableNCT06118554

3D Printing to Improve Nasal Irrigation Outcome

3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.


Sponsor

Ohio State University

Enrollment

200 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).

Exclusion Criteria1

  • 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.

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Interventions

OTHERIrrigation head position

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.


Locations(1)

The Ohio State University Eye and Ear Institue

Columbus, Ohio, United States

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NCT06118554


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