Using 3D printing to enhance nasal irrigation for chronic rhinosinusitis
3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.
This study is testing if 3D printed models of patients' noses can help people with chronic rhinosinusitis use nasal irrigation more effectively and feel better without surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06118554 on ClinicalTrials.gov |
What this trial studies
This research utilizes three-dimensional (3D) printing technology to create personalized models of patients' nasal anatomy, aiming to improve the effectiveness of nasal irrigation treatments for chronic rhinosinusitis. By providing a hand-held device that helps patients understand their unique nasal structure, the study seeks to enhance irrigation techniques and ultimately improve patient satisfaction and quality of life. The focus is on patients who are not candidates for surgery or prefer less invasive treatment options. The study will evaluate the impact of these personalized models on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with chronic rhinosinusitis, either with or without nasal polyps.
Not a fit: Patients with significant nasal polyps or other specific conditions like cystic fibrosis or connective tissue disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from chronic rhinosinusitis by enhancing the effectiveness of non-surgical treatments.
How similar studies have performed: While the use of 3D printing in medical applications is growing, this specific approach to enhancing nasal irrigation outcomes is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP). Exclusion Criteria: * 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.
Where this trial is running
Columbus, Ohio
- The Ohio State University Eye and Ear Institue — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Kai Zhao, PhD
- Email: zhao.1949@osu.edu
- Phone: 2673032322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.