3D Printing to Improve Nasal Irrigation Outcome
Key facts
- Who runs it
- Ohio State University
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Nov 2021
- Expected to end
- 30 Dec 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Irrigation head position
- Record updated
- 26 May 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP)
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- The Ohio State University Eye and Ear InstitueColumbus, United StatesContact: Kai Zhao, PhDTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Control groupExisting treatment, for comparison
The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt.
Treatment: Irrigation head position
- Backfill groupTreatment being tested
Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground.
Treatment: Irrigation head position
- Model groupTreatment being tested
Finally, the model group (MG) irrigated in an optimal position based on their 3D nasal replica. This patient-specific position was communicated to each MG patient with clear instructions during an in-person training session.
Treatment: Irrigation head position
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.
- Fit questions
- Built from NCT06118554, who can take part
- Record updated
- 26 May 2026