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

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Device: Middle Turbinate Implant

• Registration Number: NCT00896883
• Lead Sponsor: ENTrigue Surgical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Primary Completion: 2009-11
• Study Completion: 2010-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Middle Turbinate Implant	Middle Turbinate Implant	Subjects to receive Middle Turbinate Implant

Primary Outcome Measures

Name	Time	Method
Functional performance of the MTI	1 month

Secondary Outcome Measures

Name	Time	Method
Visual tissue reaction to the Middle Turbinate Implant	1 month

Trial Locations

Locations (4)

Texas Sinus Center; 🇺🇸 Boerne, Texas, United States

San Antonio Ear, Nose and Throat Research; 🇺🇸 San Antonio, Texas, United States

Texas ENT and Allergy; 🇺🇸 College Station, Texas, United States

Becker Nose and Sinus Center; 🇺🇸 Sewell, New Jersey, United States