Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum (MTI)
This study has been completed.
Sponsor:
ENTrigue Surgical, Inc.
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00896883
First received: May 8, 2009
Last updated: August 21, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sinusitis |
Device: Middle Turbinate Implant |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum |
Resource links provided by NLM:
Further study details as provided by ENTrigue Surgical, Inc.:
Primary Outcome Measures:
- Functional performance of the MTI [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual tissue reaction to the Middle Turbinate Implant [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Middle Turbinate Implant
Subjects to receive Middle Turbinate Implant
|
Device: Middle Turbinate Implant
Middle Turbinate Implant placement at time of surgery and follow ups.
Other Name: MTI
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896883
Locations
| United States, New Jersey | |
| Becker Nose and Sinus Center | |
| Sewell, New Jersey, United States, 08080 | |
| United States, Texas | |
| Texas Sinus Center | |
| Boerne, Texas, United States, 78006 | |
| Texas ENT and Allergy | |
| College Station, Texas, United States, 77845 | |
| San Antonio Ear, Nose and Throat Research | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
ENTrigue Surgical, Inc.
Investigators
| Principal Investigator: | Ronald B Kuppersmith, MD | Texas ENT and Allergy |
More Information
No publications provided
| Responsible Party: | ENTrigue Surgical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00896883 History of Changes |
| Other Study ID Numbers: | CSA2008-02 |
| Study First Received: | May 8, 2009 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by ENTrigue Surgical, Inc.:
|
turbinate implant sinus surgery Turbinates |
Additional relevant MeSH terms:
|
Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013