NCT02695602

Brief 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 obstruction in patients with inferior turbinate hypertrophy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

February 4, 2016

Last Update Submit

May 9, 2017

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (2)

  • Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients

    3 years post-operative

  • Measure of pain on the Visual Analog Scale

    3 years post-operative

Study Arms (2)

Microdebrider-Assisted Inferior Turbinoplasty (MAIT)

EXPERIMENTAL

Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz)

Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)

Submucous Resection (SMR)

EXPERIMENTAL

Turbinoplasty using non-powered instruments

Procedure: Submucous Resection with non powered instrument

Interventions

Microdebrider-Assisted Inferior Turbinoplasty (MAIT)PROCEDURE
Also known as: Medtronic
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Submucous Resection with non powered instrumentPROCEDURE
Also known as: Jansen-Middleton or straight through cut
Submucous Resection (SMR)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Seth Lieberman

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

March 1, 2016

Study Start

February 1, 2016

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)