Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Information source: ENTrigue Surgical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: Middle Turbinate Implant (Device)
Phase: N/A
Status: Completed
Sponsored by: ENTrigue Surgical, Inc. Official(s) and/or principal investigator(s):
Ronald B Kuppersmith, MD, Principal Investigator, Affiliation: Texas ENT and Allergy
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.
Clinical Details
Official title: A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Functional performance of the MTI
Secondary outcome: Visual tissue reaction to the Middle Turbinate Implant
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Becker Nose and Sinus Center, Sewell, New Jersey 08080, United States
Texas Sinus Center, Boerne, Texas 78006, United States
Texas ENT and Allergy, College Station, Texas 77845, United States
San Antonio Ear, Nose and Throat Research, San Antonio, Texas 78229, United States
Additional Information
Starting date: April 2009
Last updated: August 21, 2012
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