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Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum (MTI)

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Middle Turbinate Implant
Sponsored by
ENTrigue Surgical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sinusitis focused on measuring turbinate, implant, sinus surgery, Turbinates

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
  • Subject is able to provide a signed informed consent form.
  • Subject will agree to comply with all study-related procedures.

  • Subject is not pregnant at this time by confirmation of one of the following:

    • Subject is male
    • Subject not of child bearing age
    • Subject is surgically sterile
    • Subject is not pregnant per negative hCG test
    • Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

  • Subject does not meet inclusion criteria.
  • Presence of non-viable tissue at the implantation site.
  • History of septal perforation.
  • History of polyps.
  • Presence of concha bullosa.
  • Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea.
  • Subject is participating in a clinical trial which could affect the healing of the middle turbinate.
  • Subject has uncontrolled diabetes.

  • Subject is a:

    • smoker
    • severe drug abuser
    • severe alcohol abuser
  • Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.

Sites / Locations

  • Becker Nose and Sinus Center
  • Texas Sinus Center
  • Texas ENT and Allergy
  • San Antonio Ear, Nose and Throat Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Middle Turbinate Implant

Arm Description

Subjects to receive Middle Turbinate Implant

Outcomes

Primary Outcome Measures

Functional performance of the MTI

Secondary Outcome Measures

Visual tissue reaction to the Middle Turbinate Implant

Full Information

First Posted
May 8, 2009
Last Updated
August 21, 2012
Sponsor
ENTrigue Surgical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00896883
Brief Title
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Acronym
MTI
Official Title
A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ENTrigue Surgical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
turbinate, implant, sinus surgery, Turbinates

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Middle Turbinate Implant
Arm Type
Experimental
Arm Description
Subjects to receive Middle Turbinate Implant
Intervention Type
Device
Intervention Name(s)
Middle Turbinate Implant
Other Intervention Name(s)
MTI
Intervention Description
Middle Turbinate Implant placement at time of surgery and follow ups.
Primary Outcome Measure Information:
Title
Functional performance of the MTI
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Visual tissue reaction to the Middle Turbinate Implant
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery. Subject is able to provide a signed informed consent form. Subject will agree to comply with all study-related procedures. Subject is not pregnant at this time by confirmation of one of the following: Subject is male Subject not of child bearing age Subject is surgically sterile Subject is not pregnant per negative hCG test Subject does not plan on becoming pregnant and is not breast feeding during the course of the study. Exclusion Criteria: Subject does not meet inclusion criteria. Presence of non-viable tissue at the implantation site. History of septal perforation. History of polyps. Presence of concha bullosa. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea. Subject is participating in a clinical trial which could affect the healing of the middle turbinate. Subject has uncontrolled diabetes. Subject is a: smoker severe drug abuser severe alcohol abuser Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B Kuppersmith, MD
Organizational Affiliation
Texas ENT and Allergy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Becker Nose and Sinus Center
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Texas Sinus Center
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Texas ENT and Allergy
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
San Antonio Ear, Nose and Throat Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

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