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Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes

Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes

Not Recruiting
18 years and older
All
Phase N/A

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Overview

The purpose of this study is to use computers to simulate airflow in 3D construction of your nasal cavity generated from cone beam CT images. The results from computer simulations will help researchers identify the severity of cleft-induced nasal dysfunction and assess the impact of current treatment in restoring breathing function. The ultimate goal is to improve post-surgery outcomes to restore nasal breathing function to normal levels.

Eligibility

Inclusion Criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Male or female, aged ≥18 years of age.
  • Clinical diagnosis of unilateral cleft lip nasal deformity (uCLND)
  • Scheduled to undergo elective surgery for nasal obstruction
  • Scheduled to have a Cone Beam Computed Tomography (CBCT) as part of the pre- operative work-up for elective surgery.

Exclusion Criteria:

  • Prior cleft rhinoplasty or septoplasty for correction of nasal obstruction
  • Pregnant women: A pregnancy test will be performed within 48 hours of baseline
  • Patients unable or unwilling to comply with study procedures outlined in protocol

Study details
    Cleft Lip and Nose
    Nasal Obstruction

NCT04150783

Duke University

12 December 2025

FAQs

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