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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the 3D-printed nasal irrigation device for chronic rhinosinusitis treatment?

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 using a 3D-printed device might make nasal irrigation more effective by ensuring the treatment reaches the right areas. ^{1 2 3 4 5}

Is the 3D-printed nasal irrigation device safe for use in humans?

There is no specific safety data on the 3D-printed nasal irrigation device itself, but a study on 3D printer emissions showed slight reductions in lung function and minor changes in nasal secretions, suggesting potential mild effects from 3D printing materials. ^{1 6 7 8 9}

How does the 3D-printed nasal irrigation device for chronic rhinosinusitis differ from other treatments?

This treatment is unique because it uses 3D printing to create a customized nasal irrigation device that can better target the sinuses, potentially improving the delivery and effectiveness of the irrigation compared to standard devices. ^{1 3 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

3D Printing as a Planning Tool to Optimize Sinonasal Irrigation. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Endoscopic sinus surgery for recurrent sinusitis and nasal polyps]. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Repetitive simulation training with novel 3D-printed sinus models for functional endoscopic sinus surgeries. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of Sinus Deposition from an Aqueous Nasal Spray and Pressurised MDI in a Post-Endoscopic Sinus Surgery Nasal Replica. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Computational fluid dynamics simulation to compare large volume irrigation and continuous spraying during nasal irrigation. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Optimized gravity-driven intranasal drop administration delivers significant doses to the ostiomeatal complex and maxillary sinus. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary efficacy of fluticasone delivered by a novel device in recalcitrant chronic rhinosinusitis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Sinus penetration of saline solution irrigation and atomizer in a cadaveric polyp and allergic fungal sinusitis model. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effect of experimental exposures to 3-D printer emissions on nasal allergen responses and lung diffusing capacity for inhaled carbon monoxide/nitric oxide in subjects with seasonal allergic rhinitis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Three-Dimensional Printing of the Nasal Cavities for Clinical Experiments. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

An adjustable, butterfly-design, titanium-expanded polytetrafluoroethylene implant for nasal valve dysfunction: a pilot study. [2013]

12. Ireland pubmed.ncbi.nlm.nih.gov

Three dimensional printing: A review on the utility within medicine and otolaryngology. [2018]