3D Printing to Improve Nasal Irrigation Outcome

NCT06118554 | Recruiting

• 1 other identifier: 2020H0068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis Without Nasal Polyps

Keywords

3D modeling

Outcome Measures

Primary Outcomes (4)

• Nasal Obstruction Symptom Evaluation (NOSE) score

  patient-reported outcome measure

  completed at baseline and after 8 weeks of treatment.

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

  patient-reported outcome measure

  completed at baseline and after 8 weeks of treatment.

• Visual Analogue Scale (VAS) of nasal congestion score

  patient-reported outcome measure

  completed at baseline and after 8 weeks of treatment.

• Lund-Mackay (LM) score of sinus inflammation.

  Objective rating of sinus inflammation

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

Study Arms (3)

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.

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.

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.

Other: Irrigation head position

Interventions

Irrigation head position OTHER

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.

Backfill group; Control group; Model group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Eye and Ear Institue

Columbus, Ohio, 43212, United States

RECRUITING

Related Publications (6)

• Albu S. Chronic Rhinosinusitis-An Update on Epidemiology, Pathogenesis and Management. J Clin Med. 2020 Jul 18;9(7):2285. doi: 10.3390/jcm9072285.

  PMID: 32708447 BACKGROUND

• Wormald 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.

  PMID: 15564850 BACKGROUND

• Piromchai 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.

  PMID: 33364388 BACKGROUND

• Lepley 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.

  PMID: 36704822 BACKGROUND

• Zhao 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.

  PMID: 32441708 BACKGROUND

• Root 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.

  PMID: 39417152 DERIVED

Central Study Contacts

Kai Zhao, PhD

CONTACT

2673032322; zhao.1949@osu.edu

Zachary T. Root, BS

CONTACT

6145609257; zachary.root@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The study was single-blinded as the MG patients unavoidably knew of their experimental group assignment due to the provided 3D-printed nasal model. However, patients in BG and CG were not told the existence of other groups. Clinical providers were blinded to the patients' assigned group when assessing clinical outcomes and Lund-Mackay score, and the principal investigator was blinded to the patients' clinical outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2021
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)