Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum - Full Text View

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

This study has been terminated.

First Received on May 8, 2009. Last Updated on August 5, 2010 History of Changes

Sponsor:	ENTrigue Surgical, Inc.
Information provided by:	ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:	NCT00896883

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:

MedlinePlus related topics: Sinusitis

Drug Information available for: Statrol Neocidin Neosporin

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	April 2009
Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (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

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:	Timothy Hunt - Clinical/Regulatory Associate, 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 5, 2010
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 09, 2012