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

ENTrigue Surgical

Status

Completed

Conditions

Sinusitis

Treatments

Device: Middle Turbinate Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00896883

CSA2008-02

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.