RecruitingNot Applicable

3D Printing to Improve Nasal Irrigation Outcome

United States200 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nasal Obstruction Symptom Evaluation (NOSE) score

Timeframe: completed at baseline and after 8 weeks of treatment.

22-item Sino-Nasal Outcome Test (SNOT-22) score

Timeframe: completed at baseline and after 8 weeks of treatment.

Visual Analogue Scale (VAS) of nasal congestion score

Timeframe: completed at baseline and after 8 weeks of treatment.

Lund-Mackay (LM) score of sinus inflammation.

Timeframe: assessed from CT scans taken at baseline and after 8 weeks of treatment.

Trial details

NCT IDNCT06118554

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-26

Contact for this trial

Kai Zhao, PhD

2673032322 zhao.1949@osu.edu

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Nasal Obstruction Symptom Evaluation (NOSE) score

Timeframe: completed at baseline and after 8 weeks of treatment.

22-item Sino-Nasal Outcome Test (SNOT-22) score

Timeframe: completed at baseline and after 8 weeks of treatment.

Visual Analogue Scale (VAS) of nasal congestion score

Timeframe: completed at baseline and after 8 weeks of treatment.

Lund-Mackay (LM) score of sinus inflammation.

Timeframe: assessed from CT scans taken at baseline and after 8 weeks of treatment.