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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00896883
First received: May 8, 2009
Last updated: August 21, 2012
Last verified: August 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual tissue reaction to the Middle Turbinate Implant [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00896883     History of Changes
Other Study ID Numbers: CSA2008-02
Study First Received: May 8, 2009
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014