Nasal ObstructionNCT05287841
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
A study testing Batten batten graft, Septoplasty and Inferior Turbinate Reduction in people with Nasal Obstruction and Septal Defect, run by Northwell Health at 3 sites in United States.
Trial summary
The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction, Septal Defect, Allergic Rhinitis
- What is being tested?
- Batten batten graft, Septoplasty and Inferior Turbinate Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2021to 26 Feb 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should satisfy all the following criteria to be considered eligible for randomization:
- Be age 18 or above
- Able to provide written informed consent
- Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.
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- Septal deviation must be present on direct or endoscopic examination
Show all 11Show fewer
- Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
- Collapse of external nasal valve and/or lateral motion instability must be documented
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- The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.
- In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.
Who cannot join
- Septal perforation
- History of previous functional rhinoplasty or sinus or septal surgery
- Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
- Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
- Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lenox Hill Hospital/Staten Island University Hospital
New York, New York, 10075
Poplar Bluff Regional Medical Center
Poplar Bluff, Missouri, 63901
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.
Read the detailed description
One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.
- Being tested
- Batten batten graft, Septoplasty, Inferior Turbinate Reduction
- Medical subject headings
- Nasal Obstruction, Heart Septal Defects, Rhinitis, Allergic, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Batten batten graftProcedure or surgery
The batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration.
SeptoplastyProcedure or surgery
A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
Inferior Turbinate ReductionProcedure or surgery
The bilateral inferior turbinates will be surgically ablated.
| Study group | Role | What they receive |
|---|---|---|
| Batten graft, plus septoplasty and inferior turbinate reduction | Experimental | In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction. Receives: Procedure: Batten batten graft; Procedure: Septoplasty; Procedure: Inferior Turbinate Reduction |
| Septoplasty and inferior turbinate reduction alone | Active comparator | In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction. Receives: Procedure: Septoplasty; Procedure: Inferior Turbinate Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction Symptom Evaluation (NOSE) score
- The NOSE scale is a scoring scale from 0 to 4 (0 = no problem for quality of life, 4 = a severe problem) under 5 different parameters
- The sum of 5 different parameters are added up to give a range of possible sums from 0-20. This sum is then multiplied by 5 to give a final score with range 0-100.
Ref: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the nasal obstruction symptom evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157-163
Measured: 12 months
Secondary outcomes (5)
Lateral Wall Insufficiency (LWI) scores
Blinded, and derived by independent physician watching recorded videos 2. Grading system for lateral nasal wall collapse (0-100%). (1) Identify the junction of the upper and lower cartilages (black arrow) just above the recurvature of the lower lateral cartilage. (2) Imagine a line parallel to the nasal floor across to the septum. (3) Estimate the degree of collapse during inspiration as a percentage compared with repose.
Ref: Tsao GJ, Fijalkowski N, Most SP. Validation of a grading system for lateral nasal wall insufficiency. Allergy Rhinol (Providence) 2013;4:e66-e68
Measured: 12 months
Peak Inspiratory Flow Rate (PIFR)
Peak inspiratory flow rate ( PIFR ) is the maximum amount of air that can be inhaled over the time course of 1 deep breath, measured in L/min. This will be measured with a nasal spirometer.
Measured: 12 months
Complications and side-effects
Measured using the the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Reference https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
Measured: 12 months
Cost-effectiveness (EQ-5D-5L)
EQ-5D-5L is a standardized measure of health-related quality of life and validated for QALYs in rhinology research.
Estimated total cost of each treatment arm per patient/Estimated QALY derived from EQ-5D-5L per patient = cost-per-QALY
Reference:
Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X Qual Life Res 2011 Dec;20(10):1727-1736
Measured: 12 month
Reoperation incidence
Measured as incidence of any reoperation within study follow-up period (12 months) divided by the number of total enrollees x 100%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start4 May 2021
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The total number of subjects to be accrued locally is 96. We expect 96 patients to be pre-screened, enrolled (consent obtained), randomized, and complete research procedures. Each arm will have 48 patients. 48 patients in two arms for total of 96 patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hiltzik, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287841
- Sponsor's protocol ID
- 21-0204
- Status last verified
- Sep 2026
- First submitted
- 17 May 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05287841
- Acronym / sponsor ID
- 21-0204
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 18 Mar 2022 (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 objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.
Detailed description
One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The total number of subjects to be accrued locally is 96. We expect 96 patients to be pre-screened, enrolled (consent obtained), randomized, and complete research procedures. Each arm will have 48 patients. 48 patients in two arms for total of 96 patients.
| Arm | Type | Receives |
|---|---|---|
| Batten graft, plus septoplasty and inferior turbinate reduction | Experimental | Procedure: Batten batten graft, Procedure: Septoplasty, Procedure: Inferior Turbinate ReductionIn the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction. |
| Septoplasty and inferior turbinate reduction alone | Active comparator | Procedure: Septoplasty, Procedure: Inferior Turbinate ReductionIn the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients should satisfy all the following criteria to be considered eligible for randomization:
- <!-- -->
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- In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.
Key exclusion criteria (5 listed)
- Septal perforation
- History of previous functional rhinoplasty or sinus or septal surgery
- Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
- Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
- Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
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 |
|---|---|---|
| Batten batten graftThe batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration. | Procedure or surgery | Batten graft, plus septoplasty and inferior turbinate reduction |
| SeptoplastyA portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty. | Procedure or surgery | Batten graft, plus septoplasty and inferior turbinate reduction, Septoplasty and inferior turbinate reduction alone |
| Inferior Turbinate ReductionThe bilateral inferior turbinates will be surgically ablated. | Procedure or surgery | Batten graft, plus septoplasty and inferior turbinate reduction, Septoplasty and inferior turbinate reduction alone |
Primary outcome
Nasal Obstruction Symptom Evaluation (NOSE) score
Time frame: 12 months
1. The NOSE scale is a scoring scale from 0 to 4 (0 = no problem for quality of life, 4 = a severe problem) under 5 different parameters 2. The sum of 5 different parameters are added up to give a range of possible sums from 0-20. This sum is then multiplied by 5 to give a final score with range 0-100. Ref: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the nasal obstruction symptom evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157-163
5 secondary outcomes
Lateral Wall Insufficiency (LWI) scores
Time frame: 12 months
Peak Inspiratory Flow Rate (PIFR)
Time frame: 12 months
Complications and side-effects
Time frame: 12 months
Cost-effectiveness (EQ-5D-5L)
Time frame: 12 month
Reoperation incidence
Time frame: 12 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 13 Oct 2026.
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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.
David Hiltzik, MD principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Batten batten graft, Septoplasty and Inferior Turbinate Reduction in people with Nasal Obstruction and Septal Defect, run by Northwell Health at 3 sites 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 11 inclusion and 5 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Nasal Obstruction Symptom Evaluation (NOSE) score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.