A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery (MISTY)
June 3, 2013 updated by: ENTrigue Surgical, Inc.
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.
Study Overview
Detailed Description
MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Fresno, California, United States, 93720
- Central California ENT Medical Group
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Colorado
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Colorado Springs, Colorado, United States, 80909
- Colorado ENT & Allergy
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Kentucky
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Louisville, Kentucky, United States, 40207
- Advanced ENT and Allergy
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Texas
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McKinney, Texas, United States, 75079
- ENT Associates of Texas
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San Antonio, Texas, United States, 78229
- Ear, Nose & Throat Clinics of San Antonio
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is between the ages of 18 and 65 years
- Subject scheduled to undergo bilateral endoscopic sinus surgery
- Subject signs IRB-approved informed consent form
- Subject agrees to comply with all study-related procedures
Exclusion Criteria:
- History of removal of one or both middle turbinates
- Significant sinonasal polyps
- Presence of marked septal asymmetry
- Presence of significant concha bullosa, which requires surgical excision
- Presence of non-viable tissue at the implantation site
- Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
- Known or suspected allergy to device components
- Participating in another clinical trial which could affect the healing of the middle turbinate
- Uncontrolled diabetes
- Known or suspected use of illicit drugs
- Known or suspected alcoholism
- Other medical illness that could prevent follow-up or increase the risk of surgery
- Pregnant or unwilling to take pregnancy prevention measures
- Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: MediENT
Right or left sinus cavity where MediENT will be place after randomization.
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MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned.
MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
Other Names:
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Active Comparator: MeroPack
Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.
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MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned.
MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Miller synechia score at 8 weeks
Time Frame: 8 weeks post endoscopic sinus surgery
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Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)
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8 weeks post endoscopic sinus surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Miller Score at 4 & 8 weeks
Time Frame: 4 & 8 weeks post endoscopic sinus surgery
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4 & 8 weeks post endoscopic sinus surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
November 21, 2012
First Submitted That Met QC Criteria
November 26, 2012
First Posted (Estimate)
November 27, 2012
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
June 3, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CSA2011-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.