Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Information source: ENTrigue Surgical, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: Middle Turbinate Implant (Device)
Phase: N/A
Status: Recruiting
Sponsored by: ENTrigue Surgical, Inc. Official(s) and/or principal investigator(s):
Ronald B Kuppersmith, MD, Principal Investigator, Affiliation: Texas ENT and Allergy
Overall contact:
Gabriele G Niederauer, PhD, Phone: 210-298-6398, Ext: 6336, Email: gabi.niederauer@entriguesurgical.com
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: Prevention, Open Label, Single Group Assignment, Safety/Efficacy Study
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
Gabriele G Niederauer, PhD, Phone: 210-298-6398, Ext: 6336, Email: gabi.niederauer@entriguesurgical.com
Becker Nose and Sinus Center, Sewell, New Jersey 08080, United States; Recruiting
Daniel G Becker, MD, Phone: 856-589-6673
Patti Adamson, RN, Phone: 856-589-6673
Daniel G Becker, MD, Principal Investigator
Texas ENT and Allergy, College Station, Texas 77845, United States; Recruiting
Lisa Hastings, Phone: 979-693-6000, Email: lhastings@texasentandallergy.com
Ronald B Kuppersmith, MD, Principal Investigator
Texas Sinus Center, Boerne, Texas 78006, United States; Recruiting
Monica Moreno, Phone: 830-816-3838, Email: monica@texassinuscenter.com
James H Atkins, Jr., MD, Principal Investigator
San Antonio Ear, Nose and Throat Research, San Antonio, Texas 78229, United States; Recruiting
Diana H Henderson, MD, Phone: 210-558-7029, Email: dhenderson@saentresearch.com
Peggy Smith, Phone: 210-558-7029, Email: psmith@saentresearch.com
Diana H Henderson, MD, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: October 2009
Last updated: June 19, 2009
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