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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896883
First Posted: May 12, 2009
Last Update Posted: August 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.
  Purpose
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.

Condition Intervention
Sinusitis Device: Middle Turbinate Implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

Resource links provided by NLM:


Further study details as provided by ENTrigue Surgical, Inc.:

Primary Outcome Measures:
  • Functional performance of the MTI [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Visual tissue reaction to the Middle Turbinate Implant [ Time Frame: 1 month ]

Enrollment: 18
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Middle Turbinate Implant
Subjects to receive Middle Turbinate Implant
Device: Middle Turbinate Implant
Middle Turbinate Implant placement at time of surgery and follow ups.
Other Name: MTI

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896883


Locations
United States, New Jersey
Becker Nose and Sinus Center
Sewell, New Jersey, United States, 08080
United States, Texas
Texas Sinus Center
Boerne, Texas, United States, 78006
Texas ENT and Allergy
College Station, Texas, United States, 77845
San Antonio Ear, Nose and Throat Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ENTrigue Surgical, Inc.
Investigators
Principal Investigator: Ronald B Kuppersmith, MD Texas ENT and Allergy
  More Information

Responsible Party: ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00896883     History of Changes
Other Study ID Numbers: CSA2008-02
First Submitted: May 8, 2009
First Posted: May 12, 2009
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by ENTrigue Surgical, Inc.:
turbinate
implant
sinus surgery
Turbinates

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases