Cleft Lip and NoseNCT04150783
Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes
An observational study of Cleft Lip and Nose and Nasal Obstruction, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cleft Lip and Nose, Nasal Obstruction
- What is being tested?
- Surgical repair for nasal obstruction
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center and affiliated practices
Durham, North Carolina, 27710
About this study
Official title: Computational Modeling of the Mature Unilateral Cleft Lip Nasal Deformity for Objective Assessment of Patient Nasal Function and Treatment Outcomes
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.
- Conditions
- Cleft Lip and Nose, Nasal Obstruction
- Being tested
- Surgical repair for nasal obstruction
- Medical subject headings
- Cleft Lip, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repair for nasal obstructionProcedure or surgery
Also called observational, patient reported outcome measures
Patient reported quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Cleft Lip Nasal Deformity (uCLND) | uCLND patients who are scheduled to undergo surgical treatment for nasal obstruction as standard of care. Receives: Procedure: Surgical repair for nasal obstruction | |
| Healthy Subjects | Existing data from healthy subjects with no prior symptoms of nasal obstruction used to create normative ranges for comparison to uCLND cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of computational fluid dynamics simulation with breathing measurement
Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance from rhinomanometry breathing measurement
Measured: 6 months
Validation of computational fluid dynamics simulation with in vitro experiment
Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance measurement from in vitro experiment of 3D printed plastic nasal replica
Measured: 6 months
Effectiveness of current surgery in restoring nasal function based on volumetric airflow
Analysis of significant difference in volumetric airflow rate between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Measured: 6 months
Effectiveness of current surgery in restoring nasal function based on nasal resistance
Analysis of significant difference in nasal resistance between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images
Measured: 6 months
Effectiveness of current surgery in restoring nasal function based on nasal heat flux
Analysis of significant difference in nasal heat flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Measured: 6 months
Effectiveness of current surgery in restoring nasal function based on nasal moisture flux
Analysis of significant difference in nasal moisture flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Measured: 6 months
Anatomical sites of greatest nasal obstruction
Analysis on agreement of computational fluid dynamics identified anatomical sites of greatest nasal obstruction from pre-surgery 3D nasal models and actual surgical anatomical sites. CFD identified sites of greatest nasal obstruction are regions in the airway with highest nasal resistance.
Measured: 6 months
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computational fluid dynamics generated unilateral left and right side percent asymmetric will be computed used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Measured: 6 months
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal resistance will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Measured: 6 months
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal moisture flux will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Measured: 6 months
Secondary outcomes (5)
Change in patient-reported outcome (PRO) measures
Change PRO measures as measured by NOSE questionnaire
Measured: baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures
Change PRO measures as measured by SCHNOS questionnaire
Measured: baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures
Change PRO measures as measured by CLEFT-Q questionnaire
Measured: baseline, 2 weeks, 8 weeks, 6 months, 12 months
in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure
in vitro analysis from 3D printed plastic nasal replica of top three virtual surgery nasal models with best treatment potential will be done using unilateral airflow pressure.
Measured: 6 months
in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow
in vitro analysis from 3D printed plastic nasal replica of top three virtual surgery nasal models with best treatment potential will be done using unilateral volumetric airflow rate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019
- Primary completion31 Jan 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and NoseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Dennis Frank-Ito, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150783
- Sponsor's protocol ID
- Pro00102005
- Other IDs
- R01DE028554
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2019
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Russel SM, Chiang H, Finlay JB, Shah R, Marcus JR, Jang DW, Abi Hachem R, Goldstein BJ, Frank-Ito DO. Characterizing Olfactory Dysfunction in Patients with Unilateral Cleft Lip Nasal Deformities. Facial Plast Surg Aesthet Med. 2023 Nov-Dec;25(6):457-465. doi: 10.1089/fpsam.2022.0367. Epub 2023 May 2.
PubMed 37130297
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Modeling of the Mature Unilateral Cleft Lip Nasal Deformity for Objective Assessment of Patient Nasal Function and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT04150783
- Acronym / sponsor ID
- Pro00102005
- Conditions
- Cleft Lip and Nose, Nasal Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Cleft Lip Nasal Deformity (uCLND) | – | Procedure: Surgical repair for nasal obstructionuCLND patients who are scheduled to undergo surgical treatment for nasal obstruction as standard of care. |
| Healthy Subjects | – | –Existing data from healthy subjects with no prior symptoms of nasal obstruction used to create normative ranges for comparison to uCLND cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical repair for nasal obstructionAlso: observational, patient reported outcome measuresPatient reported quality of life questionnaires | Procedure or surgery | Unilateral Cleft Lip Nasal Deformity (uCLND) |
Primary outcome
Validation of computational fluid dynamics simulation with breathing measurement
Time frame: 6 months
Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance from rhinomanometry breathing measurement
Validation of computational fluid dynamics simulation with in vitro experiment
Time frame: 6 months
Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance measurement from in vitro experiment of 3D printed plastic nasal replica
Effectiveness of current surgery in restoring nasal function based on volumetric airflow
Time frame: 6 months
Analysis of significant difference in volumetric airflow rate between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Effectiveness of current surgery in restoring nasal function based on nasal resistance
Time frame: 6 months
Analysis of significant difference in nasal resistance between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images
Effectiveness of current surgery in restoring nasal function based on nasal heat flux
Time frame: 6 months
Analysis of significant difference in nasal heat flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Effectiveness of current surgery in restoring nasal function based on nasal moisture flux
Time frame: 6 months
Analysis of significant difference in nasal moisture flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Anatomical sites of greatest nasal obstruction
Time frame: 6 months
Analysis on agreement of computational fluid dynamics identified anatomical sites of greatest nasal obstruction from pre-surgery 3D nasal models and actual surgical anatomical sites. CFD identified sites of greatest nasal obstruction are regions in the airway with highest nasal resistance.
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow
Time frame: 6 months
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computational fluid dynamics generated unilateral left and right side percent asymmetric will be computed used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance
Time frame: 6 months
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal resistance will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux
Time frame: 6 months
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal moisture flux will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
5 secondary outcomes
Change in patient-reported outcome (PRO) measures
Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures
Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
Change in patient-reported outcome (PRO) measures
Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months
in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure
Time frame: 6 months
in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 37130297Russel SM, Chiang H, Finlay JB, Shah R, Marcus JR, Jang DW, Abi Hachem R, Goldstein BJ, Frank-Ito DO. Characterizing Olfactory Dysfunction in Patients with Unilateral Cleft Lip Nasal Deformities. Facial Plast Surg Aesthet Med. 2023 Nov-Dec;25(6):457-465. doi: 10.1089/fpsam.2022.0367. Epub 2023 May 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Frank-Ito, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Nose and Nasal Obstruction, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of computational fluid dynamics simulation with breathing measurement (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04150783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.