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

Completed · Not applicable

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT00896883

Run by

ENTrigue Surgical, Inc.

People needed

18

Starts

2009-04-01

Expected to finish

2010-05-01

Last updated by the study team

2012-08-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Becker Nose and Sinus Center — Sewell, New Jersey, United States
• Texas Sinus Center — Boerne, Texas, United States
• Texas ENT and Allergy — College Station, Texas, United States
• San Antonio Ear, Nose and Throat Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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