CompletedNot Applicable

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

United States12 participantsStarted 2019-11-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Validation of computational fluid dynamics simulation with breathing measurement

Timeframe: 6 months

Validation of computational fluid dynamics simulation with in vitro experiment

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on volumetric airflow

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal resistance

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal heat flux

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal moisture flux

Timeframe: 6 months

Anatomical sites of greatest nasal obstruction

Timeframe: 6 months

Trial details

NCT IDNCT04150783

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Cleft Lip and Nose trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Validation of computational fluid dynamics simulation with breathing measurement

Timeframe: 6 months

Validation of computational fluid dynamics simulation with in vitro experiment

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on volumetric airflow

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal resistance

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal heat flux

Timeframe: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal moisture flux

Timeframe: 6 months

Anatomical sites of greatest nasal obstruction

Timeframe: 6 months