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

Sinusitis Clinical Trial

— MTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896883
• Other study ID #: CSA2008-02
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: August 21, 2012
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2012
• Source: ENTrigue Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sinusitis

Intervention

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

Locations

Country	Name	City	State
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	Becker Nose and Sinus Center	Sewell	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
ENTrigue Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional performance of the MTI		1 month	No
Secondary	Visual tissue reaction to the Middle Turbinate Implant		1 month	Yes