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3D-Printed Nasal Irrigation Device for Chronic Rhinosinusitis

N/A

Waitlist Available

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completed at baseline and after 8 weeks of treatment.

Awards & highlights

Study Summary

This trial is exploring a 3D-printed device to help people with chronic rhinosinusitis better understand their anatomy & maximize treatment efficacy for improved quality of life.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the intervention involves non-invasive educational tools rather than medication or surgery, there are no direct side effects from the device itself. However, typical risks associated with improper nasal irrigation may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic sinusitis, with or without nasal polyps.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completed at baseline and after 8 weeks of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completed at baseline and after 8 weeks of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and completed at baseline and after 8 weeks of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Lund-Mackay (LM) score of sinus inflammation.

Nasal Obstruction Symptom Evaluation (NOSE) score

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Model groupExperimental Treatment1 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 groupExperimental Treatment1 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 groupActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,751 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals eligible to partake in this scientific investigation?

"The details from clinicaltrials.gov convey that the study is not currently engaging with potential participants, as it was last edited on November 1st 2023. Although this trial isn't taking candidates at present, there are 110 other trials actively recruiting patients."

Answered by AI

Could I qualify to join in this medical experiment?

"The prerequisites for entry into this clinical trial are a diagnosis of chronic rhinosinusitis and an age between 18-75. This research is looking to include 62 individuals in the experiment."

Answered by AI

Is the age criterion for this clinical trial restricted to those below 45 years of age?

"Candidates between the ages of 18 and 75 are eligible for this study. Those under 18 can take part in 7 different trials, while those over 65 have access to 104 distinct studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

3D Printing to Improve Nasal Irrigation Outcome

Kai Zhao 2021. "3D Printing to Improve Nasal Irrigation Outcome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118554.