NCT00896883CompletedNot Applicable
A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ENTrigue Surgical, Inc.
- Enrollment
- 18
- Locations
- 8
- Primary Endpoint
- Functional performance of the MTI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •severe drug abuser
- •severe alcohol abuser
- •Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
Outcomes
Primary Outcomes
Functional performance of the MTI
Time Frame: 1 month
Secondary Outcomes
- Visual tissue reaction to the Middle Turbinate Implant(1 month)
Investigators
Study Sites (8)
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