Nasal ObstructionNCT02695602
Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
A study testing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) and Submucous Resection with non powered instrument in people with Nasal Obstruction, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Microdebrider-Assisted Inferior Turbinoplasty (MAIT) and Submucous Resection with non powered instrument
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 9 May 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy, with or without septal deviation will be eligible for the study.
- Failed medical treatment
- Have failed medical treatment for at least 1 month, and will be offered surgery
- Patients having Septoplasty at the same time as their turbinate reduction surgery.
Who cannot join
- Patients who have had previous turbinate reduction surgery will be excluded.
- Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal tumors, or any other exam finding that would explain their symptoms of nasal obstruction other than enlarged inferior turbinates with or without septal deviation will be excluded.
- Patients who are diagnosed with purely bony inferior turbinate hypertrophy as discussed below.
- Patients on hormone or anticoagulation therapy and those who have a history of head and neck radiation therapy will be excluded.
- All study candidates will be assessed for external nasal valve collapse via the modified Cottle maneuver, and will be excluded if they exhibit significant external or internal nasal valve collapse as their primary cause of their nasal obstruction.
- All patients will complete the Visual Analog Scale (VAS) on nasal obstruction before and after decongestion at their preoperative visit. Patients that fail to report a score less than 5 after decongestion are likely to have bony rather than soft tissue hypertrophy. In these patients MAIT is unlikely to be an adequate surgical option, and they would derive a greater amount of benefit from SMR. Therefore these patients will be excluded from the study, and offered only SMR.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal obstruction in patients with inferior turbinate hypertrophy.
- Conditions
- Nasal Obstruction
- Being tested
- Microdebrider-Assisted Inferior Turbinoplasty (MAIT), Submucous Resection with non powered instrument
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)Procedure or surgery
Also called Medtronic
Submucous Resection with non powered instrumentProcedure or surgery
Also called Jansen-Middleton or straight through cut
| Study group | Role | What they receive |
|---|---|---|
| Microdebrider-Assisted Inferior Turbinoplasty (MAIT) | Experimental | Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz) Receives: Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT) |
| Submucous Resection (SMR) | Experimental | Turbinoplasty using non-powered instruments Receives: Procedure: Submucous Resection with non powered instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
Measured: 3 years post-operative
Measure of pain on the Visual Analog Scale
Measured: 3 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion9 May 2017
- Study completion9 May 2017
Why it stopped: Unable to recruit enough patients
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 NYU Langone 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Lieberman, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695602
- Sponsor's protocol ID
- 15-01264
- Status last verified
- May 2017
- First submitted
- 4 Feb 2016
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
- ClinicalTrials.gov ID
- NCT02695602
- Acronym / sponsor ID
- 15-01264
- Conditions
- Nasal Obstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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.
This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal obstruction in patients with inferior turbinate hypertrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microdebrider-Assisted Inferior Turbinoplasty (MAIT) | Experimental | Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz) |
| Submucous Resection (SMR) | Experimental | Procedure: Submucous Resection with non powered instrumentTurbinoplasty using non-powered instruments |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy, with or without septal deviation will be eligible for the study.
- Failed medical treatment
- Have failed medical treatment for at least 1 month, and will be offered surgery
- Patients having Septoplasty at the same time as their turbinate reduction surgery.
Key exclusion criteria (6 listed)
- Patients who have had previous turbinate reduction surgery will be excluded.
- Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal tumors, or any other exam finding that would explain their symptoms of nasal obstruction other than enlarged inferior turbinates with or without septal deviation will be excluded.
- Patients who are diagnosed with purely bony inferior turbinate hypertrophy as discussed below.
- Patients on hormone or anticoagulation therapy and those who have a history of head and neck radiation therapy will be excluded.
- All study candidates will be assessed for external nasal valve collapse via the modified Cottle maneuver, and will be excluded if they exhibit significant external or internal nasal valve collapse as their primary cause of their nasal obstruction.
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 |
|---|---|---|
| Microdebrider-Assisted Inferior Turbinoplasty (MAIT)Also: Medtronic | Procedure or surgery | Microdebrider-Assisted Inferior Turbinoplasty (MAIT) |
| Submucous Resection with non powered instrumentAlso: Jansen-Middleton or straight through cut | Procedure or surgery | Submucous Resection (SMR) |
Primary outcome
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
Time frame: 3 years post-operative
Measure of pain on the Visual Analog Scale
Time frame: 3 years post-operative
Results and safety
The study was stopped early (reason given: Unable to recruit enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
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Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
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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.
Seth Lieberman principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) and Submucous Resection with non powered instrument in people with Nasal Obstruction, run by NYU Langone Health 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 May 2017. 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 was stopped early (reason given: Unable to recruit enough patients). Results are not available in the source record.
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?
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients (time frame: 3 years post-operative). The study lists 2 primary outcomes in all. 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 10 May 2017.