Trial Comparing Microdebrider-Assisted Inferior Turbinopl... | NCT02695602

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

NCT02695602

Sponsor

NYU Langone Health

Status

Terminated

Last Update Posted

May 10, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Nasal Obstruction

Interventions

Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Submucous Resection with non powered instrument

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit enough patients

Expanded Access Info

Start Date

Feb 2016Actual

Primary Completion Date

May 9, 2017Actual

Completion Date

May 9, 2017Actual

First Submitted Date

Feb 4, 2016

First Submission Date that Met QC Criteria

Feb 24, 2016

First Posted Date

Mar 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2017

Last Update Posted Date

May 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)	Procedure		Microdebrider-Assisted Inferior Turbinoplasty (MAIT)	Medtronic

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency