3D Printing to Improve Nasal Irrigation Outcome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOhio State University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Irrigation head position
Other interventionPatients 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.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Backfill groupExperimental treatment 1 intervention
Group C: Model groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Nasal Obstruction Symptom Evaluation (NOSE) score
patient-reported outcome measure
Time frame
completed at baseline and after 8 weeks of treatment.2
22-item Sino-Nasal Outcome Test (SNOT-22) score
patient-reported outcome measure
Time frame
completed at baseline and after 8 weeks of treatment.3
Visual Analogue Scale (VAS) of nasal congestion score
patient-reported outcome measure
Time frame
completed at baseline and after 8 weeks of treatment.4
Lund-Mackay (LM) score of sinus inflammation.
Objective rating of sinus inflammation
Time frame
assessed from CT scans taken at baseline and after 8 weeks of treatment.Sponsors and contacts
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Source ClinicalTrials.gov