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

Duke University

Status

Completed

Conditions

Cleft Lip and Nose

Nasal Obstruction

Treatments

Procedure: Surgical repair for nasal obstruction

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04150783

Pro00102005

R01DE028554 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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