3D-Printed Nasal Irrigation Device for Chronic Rhinosinusitis

Overseen By Zachary T. Root, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Significant nasal polyps, Cystic fibrosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 3D-printed nasal irrigation device can assist people with chronic rhinosinusitis, a condition that causes stuffy and inflamed sinuses. The research tests whether a personalized 3D model of the nose can enhance the effectiveness of nasal irrigation, potentially improving comfort and quality of life. Participants will be divided into groups, each trying different head positions during irrigation. Individuals with chronic rhinosinusitis, both with and without nasal polyps, but without significant nasal polyps or certain other conditions, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve treatment for chronic rhinosinusitis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 3D-printed nasal irrigation device is safe for chronic rhinosinusitis?

Research shows that a 3D-printed nasal irrigation device may help people manage chronic rhinosinusitis more effectively. However, specific safety information for this device is not yet available. As this treatment remains in early research stages, comprehensive safety data for humans might not be fully accessible.

The device is not implanted in the body; it is a handheld tool that aids in understanding nasal anatomy. This suggests a low risk of side effects when used correctly. Prospective trial participants should discuss any concerns with the research team to understand all potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized nasal irrigation using 3D-printed nasal replicas might improve treatment for chronic rhinosinusitis, a condition usually managed with saline rinses and nasal sprays. Unlike the standard approach, which involves a one-size-fits-all head position, this trial investigates whether customizing the irrigation angle based on a patient's unique nasal structure can enhance effectiveness. The backfill group tests a novel ear-to-shoulder tilt method, while the model group uses a specially tailored position guided by a 3D-printed model of their nasal passages. This personalized approach could lead to better symptom relief and improved quality of life for patients.

What evidence suggests that this 3D-printed nasal irrigation device is effective for chronic rhinosinusitis?

Research has shown that 3D-printed models of the nose can improve nasal rinsing for people with chronic sinus issues. In this trial, participants in the model group will use these customized models to learn the optimal head position for rinsing, based on their unique nasal anatomy. Studies suggest this method delivers the rinse more effectively to the sinuses, which is crucial for successful treatment. By tailoring the approach to each person's unique anatomy, the treatment can become more effective, enhancing overall satisfaction and quality of life. These early findings are promising, but further research is needed to confirm the long-term benefits. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic rhinosinusitis, with or without nasal polyps. It's not suitable for those with certain connective tissue disorders like granulomatosis with polyangiitis, significant atopy, cystic fibrosis, or pregnant individuals.

Inclusion Criteria

I have chronic sinusitis, with or without nasal polyps.

Exclusion Criteria

You have a serious allergy condition.

I have a condition like granulomatosis with polyangiitis.

I have cystic fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized nasal irrigation treatment using 3D-printed nasal replicas for 8 weeks

8 weeks

1 in-person training session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D Printing

Trial Overview The study tests if a personalized education tool made using 3D printing can improve nasal irrigation outcomes in patients by considering their unique anatomy. The goal is to enhance satisfaction and quality of life for those who cannot undergo surgery.

How Is the Trial Designed?

Group I: Model group Experimental Treatment 1 Intervention

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.

Group II: Backfill group Experimental Treatment 1 Intervention

Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground.

Group III: Control group Active Control 1 Intervention

The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11480515/

Optimizing Corticosteroid Sinonasal Irrigation Outcomes ... We sought to determine if personalized, 3-dimensional (3D)-printed nasal models can optimize head positioning and irrigation parameters, therefore improving ...

2. trialx.com trialx.com/clinical-trials/listings/295908/3d-printing-to-improve-nasal-irrigation-outcome/

3D Printing to Improve Nasal Irrigation Outcome This research aims to use 3D printing as a tool to provide personalized education to maximize treatment efficacy based on the patient's ...

3. withpower.com withpower.com/trial/phase-sinusitis-10-2021-d85ba

3D-Printed Nasal Irrigation Device for Chronic Rhinosinusitis Research shows that 3D printing can help plan and improve the delivery of sinus irrigation, which is important for treating sinus problems. This suggests that ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10368789/

3D Printing as a Planning Tool to Optimize Sinonasal ... 3D printing to create a personalized model may present a promising technique to improve irrigation treatment outcomes for patients suffering from CRS. Currently ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024142107

Visualization and quantitative evaluation of aerosol ... The goal of this project is to propose an effective technique for visualizing and quantifying aerosol deposition in a three-dimensional adult nasal cavity.