3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

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

Locations
United States
Ohio
The Ohio State University Eye and Ear Institue
RECRUITING
Columbus
Contact Information
Primary
Kai Zhao, PhD
zhao.1949@osu.edu
2673032322
Backup
Zachary T. Root, BS
zachary.root@osumc.edu
6145609257
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 200
Treatments
Active_comparator: Control group
The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt.
Experimental: Backfill group
Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground.
Experimental: Model group
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.
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov