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

A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00896883

Acronym

MTI

Enrollment

Registered

2009-05-12

Start date

2009-04-30

Completion date

2010-05-31

Last updated

2012-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Keywords

turbinate, implant, sinus surgery, Turbinates

Brief summary

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.

Interventions

DEVICEMiddle Turbinate Implant

Middle Turbinate Implant placement at time of surgery and follow ups.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Functional performance of the MTI	1 month

Secondary

Measure	Time frame
Visual tissue reaction to the Middle Turbinate Implant	1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026