Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)

May 9, 2017 updated by: NYU Langone Health

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz)
Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Other Names:
  • Medtronic
Experimental: Submucous Resection (SMR)
Turbinoplasty using non-powered instruments
Procedure: Submucous Resection with non powered instrument
Other Names:
  • Jansen-Middleton or straight through cut

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
Time Frame: 3 years post-operative
3 years post-operative
Measure of pain on the Visual Analog Scale
Time Frame: 3 years post-operative
3 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Seth Lieberman, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

May 9, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-01264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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