Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
MTI
A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
1 other identifier
interventional
18
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 8, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedAugust 23, 2012
August 1, 2012
7 months
May 8, 2009
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional performance of the MTI
1 month
Secondary Outcomes (1)
Visual tissue reaction to the Middle Turbinate Implant
1 month
Study Arms (1)
Middle Turbinate Implant
EXPERIMENTALSubjects to receive Middle Turbinate Implant
Interventions
Middle Turbinate Implant placement at time of surgery and follow ups.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald B Kuppersmith, MD
Texas ENT and Allergy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2009
First Posted
May 12, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2009
Study Completion
May 1, 2010
Last Updated
August 23, 2012
Record last verified: 2012-08