A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
NCT ID: NCT01733667
Last Updated: 2013-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-12-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MediENT
Right or left sinus cavity where MediENT will be place after randomization.
MediENT
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
MeroPack
Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.
MeroPack
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
Interventions
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MediENT
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
MeroPack
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject scheduled to undergo bilateral endoscopic sinus surgery
3. Subject signs IRB-approved informed consent form
4. Subject agrees to comply with all study-related procedures
Exclusion Criteria
2. Significant sinonasal polyps
3. Presence of marked septal asymmetry
4. Presence of significant concha bullosa, which requires surgical excision
5. Presence of non-viable tissue at the implantation site
6. Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
7. Known or suspected allergy to device components
8. Participating in another clinical trial which could affect the healing of the middle turbinate
9. Uncontrolled diabetes
10. Known or suspected use of illicit drugs
11. Known or suspected alcoholism
12. Other medical illness that could prevent follow-up or increase the risk of surgery
13. Pregnant or unwilling to take pregnancy prevention measures
14. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea
18 Years
65 Years
ALL
No
Sponsors
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ENTrigue Surgical, Inc.
INDUSTRY
Responsible Party
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Locations
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Central California ENT Medical Group
Fresno, California, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
ENT Associates of Texas
McKinney, Texas, United States
Ear, Nose & Throat Clinics of San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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CSA2011-01
Identifier Type: -
Identifier Source: org_study_id
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