Chronic Rhinosinusitis With Nasal PolypsNCT06118554
3D Printing to Improve Nasal Irrigation Outcome
A study testing Irrigation head position in people with Chronic Rhinosinusitis With Nasal Polyps and Chronic Rhinosinusitis Without Nasal Polyps, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis Without Nasal Polyps
- What is being tested?
- Irrigation head position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Eye and Ear Institue
Columbus, Ohio, 43212
Kai Zhao, PhD, 2673032322, zhao.1949@osu.edu
Kai Zhao, PhD
About this study
Official title: 3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical 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.
Read the detailed description
Chronic rhinosinusitis (CRS) is one of the most common medical conditions in the US, affecting an estimated 13% of adults, or some 30 million people. It accounts for 12.5 million physician office visits each year and an annual health care expenditure of $5.8 billion (National Health Interview Survey 2009, CDC). Major symptoms include nasal obstruction, facial pain/pressure, nasal discharge, purulence in the nasal cavity, and loss of smell. These symptoms significantly impact patient quality of life, even compared to chronic debilitating diseases such as diabetes and congestive heart failure.
Topical therapies play an integral role in the management of CRS, and high-volume irrigation delivery (e.g., neti pot, squeeze bottles) is more effective for achieving distribution to the sinuses than other topical delivery methods such as nasal sprays, nebulizers, or atomizers. Saline irrigations have been recommended in a number of clinical scenarios, including initial management of CRS and postoperative care. High-volume irrigations have also shown benefits for medication delivery, such as with mupirocin and corticosteroids. However, due to the intricate and variable anatomy of the human nasal airway, the efficacy of topical irrigations is inconsistent and difficult to predict. Previous studies from our group and others have shown that nasal irrigant may not reliably penetrate all sinuses, and the effectiveness varies depending on specific sinuses, head positions, injection angle, pressure, flow rates, and other factors. We currently do not have a clear understanding of the optimal delivery technique(s). In efforts to improve these outcomes, the efficacy of topical irrigation delivery to target sinuses is an area of active research. Yet, investigations have been limited by labor-intensive methodologies, such as cadaver studies or using colored dyes followed by endoscopy to visualize where the irrigation might have reached. Other studies have used irrigations with iodinated contrast followed by computed tomography (CT) scans to determine which sinuses collect contrast material. Similarly, technetium 99m sulfur colloid and fluorescein have also been used as tracers to visualize the distribution of sinus irrigations. These labor-intensive techniques are difficult to apply to a large sample size. They increase patient risk and commonly capture only where the irrigation fluid has been at the end of irrigation, but not the details of irrigation flow paths that would allow us to understand why the irrigation outcomes vary.
From both patients' and clinicians' perspectives, the lack of clear prediction of patient-specific irrigation outcomes can be frustrating, as clinicians prescribe a rigorous daily irrigation routine but have no assurance that what patients are doing is effective. When symptoms fail to improve after courses of irrigation, it is difficult to determine whether the added medication is not working, or the irrigation does not reach clinically relevant targets deep within the sinuses. Many patients and surgeons thus opt for systemic medication or surgery, which increases risk of overmedication, growth of resistant organisms, systemic side effects, and serious risk from surgery.
The purpose of this study was to propose a novel idea: applying three-dimensional (3D)-printing technology based on individual patients' computed tomography (CT) scans to determine an optimal personalized nasal irrigation strategy (head positions, angle of injection, flow rates, etc.).
- Being tested
- Irrigation head position
- Keywords
- 3D modeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation head positionOther
Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks. The only factor that varied between groups was the head position patients irrigated in.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt. Receives: Other: Irrigation head position |
| Backfill group | Experimental | Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground. Receives: Other: Irrigation head position |
| Model group | Experimental | 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. Receives: Other: Irrigation head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction Symptom Evaluation (NOSE) score
patient-reported outcome measure
Measured: completed at baseline and after 8 weeks of treatment.
22-item Sino-Nasal Outcome Test (SNOT-22) score
patient-reported outcome measure
Measured: completed at baseline and after 8 weeks of treatment.
Visual Analogue Scale (VAS) of nasal congestion score
patient-reported outcome measure
Measured: completed at baseline and after 8 weeks of treatment.
Lund-Mackay (LM) score of sinus inflammation.
Objective rating of sinus inflammation
Measured: assessed from CT scans taken at baseline and after 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2021
- Primary completion26 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients were prescribed an 8-week course of daily 2 mg of mometasone irrigation (Advanced Rx Compounding Pharmacy, Fort Washington, Pennsylvania) using 240 mL Sinus Rinse bottles (NeilMed Pharmaceuticals Inc, Santa Rosa, CA). The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt. Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground. 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. All patients were required to record their daily compliance, if they changed head position, and what head position they changed to during the course of the treatment.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Zhao, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118554
- Sponsor's protocol ID
- 2020H0068
- Status last verified
- May 2026
- First submitted
- 1 Nov 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Albu S. Chronic Rhinosinusitis-An Update on Epidemiology, Pathogenesis and Management. J Clin Med. 2020 Jul 18;9(7):2285. doi: 10.3390/jcm9072285.
PubMed 32708447Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7. doi: 10.1097/01.mlg.0000149463.95950.c5.
PubMed 15564850Piromchai P, Puvatanond C, Kirtsreesakul V, Chaiyasate S, Suwanwech T. A multicenter survey on the effectiveness of nasal irrigation devices in rhinosinusitis patients. Laryngoscope Investig Otolaryngol. 2020 Nov 16;5(6):1003-1010. doi: 10.1002/lio2.497. eCollection 2020 Dec.
PubMed 33364388Lepley TJ, Kim K, Ardizzone M, Kelly KM, Otto BA, Zhao K. 3D Printing as a Planning Tool to Optimize Sinonasal Irrigation. Ann Otol Rhinol Laryngol. 2023 Nov;132(11):1306-1313. doi: 10.1177/00034894221149242. Epub 2023 Jan 26.
PubMed 36704822Zhao K, Kim K, Craig JR, Palmer JN. Using 3D printed sinonasal models to visualize and optimize personalized sinonasal sinus irrigation strategies. Rhinology. 2020 Jun 1;58(3):266-272. doi: 10.4193/Rhin19.314.
PubMed 32441708Root ZT, Lepley TJ, Kim K, Schneller AR, Zhao S, Wen R, Formanek VL, Sussman SM, Lee JS, Odeh A, Wei L, Kelly KM, Otto BA, Zhao K. Optimizing Corticosteroid Sinonasal Irrigation Outcomes Through 3D Printing: A Randomized Pilot Clinical Trial. OTO Open. 2024 Oct 16;8(4):e70036. doi: 10.1002/oto2.70036. eCollection 2024 Oct-Dec.
PubMed 39417152
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06118554
- Acronym / sponsor ID
- 2020H0068
- Keywords
- 3D modeling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic rhinosinusitis (CRS) is one of the most common medical conditions in the US, affecting an estimated 13% of adults, or some 30 million people. It accounts for 12.5 million physician office visits each year and an annual health care expenditure of $5.8 billion (National Health Interview Survey 2009, CDC). Major symptoms include nasal obstruction, facial pain/pressure, nasal discharge, purulence in the nasal cavity, and loss of smell. These symptoms significantly impact patient quality of life, even compared to chronic debilitating diseases such as diabetes and congestive heart failure.
Topical therapies play an integral role in the management of CRS, and high-volume irrigation delivery (e.g., neti pot, squeeze bottles) is more effective for achieving distribution to the sinuses than other topical delivery methods such as nasal sprays, nebulizers, or atomizers. Saline irrigations have been recommended in a number of clinical scenarios, including initial management of CRS and postoperative care. High-volume irrigations have also shown benefits for medication delivery, such as with mupirocin and corticosteroids. However, due to the intricate and variable anatomy of the human nasal airway, the efficacy of topical irrigations is inconsistent and difficult to predict. Previous studies from our group and others have shown that nasal irrigant may not reliably penetrate all sinuses, and the effectiveness varies depending on specific sinuses, head positions, injection angle, pressure, flow rates, and other factors. We currently do not have a clear understanding of the optimal delivery technique(s). In efforts to improve these outcomes, the efficacy of topical irrigation delivery to target sinuses is an area of active research. Yet, investigations have been limited by labor-intensive methodologies, such as cadaver studies or using colored dyes followed by endoscopy to visualize where the irrigation might have reached. Other studies have used irrigations with iodinated contrast followed by computed tomography (CT) scans to determine which sinuses collect contrast material. Similarly, technetium 99m sulfur colloid and fluorescein have also been used as tracers to visualize the distribution of sinus irrigations. These labor-intensive techniques are difficult to apply to a large sample size. They increase patient risk and commonly capture only where the irrigation fluid has been at the end of irrigation, but not the details of irrigation flow paths that would allow us to understand why the irrigation outcomes vary.
From both patients' and clinicians' perspectives, the lack of clear prediction of patient-specific irrigation outcomes can be frustrating, as clinicians prescribe a rigorous daily irrigation routine but have no assurance that what patients are doing is effective. When symptoms fail to improve after courses of irrigation, it is difficult to determine whether the added medication is not working, or the irrigation does not reach clinically relevant targets deep within the sinuses. Many patients and surgeons thus opt for systemic medication or surgery, which increases risk of overmedication, growth of resistant organisms, systemic side effects, and serious risk from surgery.
The purpose of this study was to propose a novel idea: applying three-dimensional (3D)-printing technology based on individual patients' computed tomography (CT) scans to determine an optimal personalized nasal irrigation strategy (head positions, angle of injection, flow rates, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- Model description
- All patients were prescribed an 8-week course of daily 2 mg of mometasone irrigation (Advanced Rx Compounding Pharmacy, Fort Washington, Pennsylvania) using 240 mL Sinus Rinse bottles (NeilMed Pharmaceuticals Inc, Santa Rosa, CA). The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt. Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground. 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. All patients were required to record their daily compliance, if they changed head position, and what head position they changed to during the course of the treatment.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Irrigation head positionThe control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt. |
| Backfill group | Experimental | Other: Irrigation head positionBackfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground. |
| Model group | Experimental | Other: Irrigation head positionFinally, 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation head positionPatients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks. The only factor that varied between groups was the head position patients irrigated in. | Other | Backfill group, Control group, Model group |
Primary outcome
Nasal Obstruction Symptom Evaluation (NOSE) score
Time frame: completed at baseline and after 8 weeks of treatment.
patient-reported outcome measure
22-item Sino-Nasal Outcome Test (SNOT-22) score
Time frame: completed at baseline and after 8 weeks of treatment.
patient-reported outcome measure
Visual Analogue Scale (VAS) of nasal congestion score
Time frame: completed at baseline and after 8 weeks of treatment.
patient-reported outcome measure
Lund-Mackay (LM) score of sinus inflammation.
Time frame: assessed from CT scans taken at baseline and after 8 weeks of treatment.
Objective rating of sinus inflammation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 32708447Albu S. Chronic Rhinosinusitis-An Update on Epidemiology, Pathogenesis and Management. J Clin Med. 2020 Jul 18;9(7):2285. doi: 10.3390/jcm9072285.
- Background: PubMed 15564850Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7. doi: 10.1097/01.mlg.0000149463.95950.c5.
- Background: PubMed 33364388Piromchai P, Puvatanond C, Kirtsreesakul V, Chaiyasate S, Suwanwech T. A multicenter survey on the effectiveness of nasal irrigation devices in rhinosinusitis patients. Laryngoscope Investig Otolaryngol. 2020 Nov 16;5(6):1003-1010. doi: 10.1002/lio2.497. eCollection 2020 Dec.
- Background: PubMed 36704822Lepley TJ, Kim K, Ardizzone M, Kelly KM, Otto BA, Zhao K. 3D Printing as a Planning Tool to Optimize Sinonasal Irrigation. Ann Otol Rhinol Laryngol. 2023 Nov;132(11):1306-1313. doi: 10.1177/00034894221149242. Epub 2023 Jan 26.
- Background: PubMed 32441708Zhao K, Kim K, Craig JR, Palmer JN. Using 3D printed sinonasal models to visualize and optimize personalized sinonasal sinus irrigation strategies. Rhinology. 2020 Jun 1;58(3):266-272. doi: 10.4193/Rhin19.314.
- Derived from this study: PubMed 39417152Root ZT, Lepley TJ, Kim K, Schneller AR, Zhao S, Wen R, Formanek VL, Sussman SM, Lee JS, Odeh A, Wei L, Kelly KM, Otto BA, Zhao K. Optimizing Corticosteroid Sinonasal Irrigation Outcomes Through 3D Printing: A Randomized Pilot Clinical Trial. OTO Open. 2024 Oct 16;8(4):e70036. doi: 10.1002/oto2.70036. eCollection 2024 Oct-Dec.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation head position in people with Chronic Rhinosinusitis With Nasal Polyps and Chronic Rhinosinusitis Without Nasal Polyps, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Zhao, PhD (2673032322, zhao.1949@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Obstruction Symptom Evaluation (NOSE) score (time frame: completed at baseline and after 8 weeks of treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118554, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.