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

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.

Completed

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Becker Nose and Sinus Center, Sewell, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Middle Turbinate Implant

Device

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

Other names: MTI

Primary outcomes

Functional performance of the MTI

Time frame: 1 month

Secondary outcomes

Visual tissue reaction to the Middle Turbinate Implant

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ENTrigue Surgical, Inc.

Industry

Registry information

Official study title

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

Acronym: MTI

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: May 12, 2009
Registry last updated: Aug 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed