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Computer simulations could help fix breathing in cleft lip patients

NCT ID NCT04150783

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study used computer simulations to analyze airflow in the noses of 12 adults with a cleft lip nasal deformity who were scheduled for surgery. The goal was to better understand how the deformity affects breathing and to help doctors plan more effective surgeries. The research did not test a new treatment but aimed to improve future surgical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Nov 2019

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with unilateral cleft lip nasal deformity scheduled to undergo elective surgery for nasal obstruction at the Duke Cleft and Craniofacial Center. Existing CBCT imaging data and QOL measures previously collected on healthy subjects will be used for comparison. Healthy subjects will not be prospectively enrolled in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cleft lip Nasal Obstruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cleft lip and nose Nasal obstruction

Contacts and locations

Locations

  • Duke University Medical Center and affiliated practices

    Durham, North Carolina, 27710, United States

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Other studies related to the condition(s) this trial covers.