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A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery (MISTY)

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ClinicalTrials.gov Identifier: NCT01733667
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.

Condition or disease Intervention/treatment Phase
Synechia Device: MediENT Device: MeroPack Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: MediENT
Right or left sinus cavity where MediENT will be place after randomization.
 Device: 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
Other Name: MeroPack
Active Comparator: MeroPack
Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. Miller synechia score at 8 weeks [ Time Frame: 8 weeks post endoscopic sinus surgery ]
    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)


Secondary Outcome Measures :
  1. Miller Score at 4 & 8 weeks [ Time Frame: 4 & 8 weeks post endoscopic sinus surgery ]
    • Miller synechia score at 4 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 4 weeks judged by an independent evaluator)
    • Total mean Miller score at 8 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is between the ages of 18 and 65 years
  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:

  1. History of removal of one or both middle turbinates
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733667


Locations
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United States, California
Central California ENT Medical Group
Fresno, California, United States, 93720
United States, Colorado
Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80909
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Texas
ENT Associates of Texas
McKinney, Texas, United States, 75079
Ear, Nose & Throat Clinics of San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ENTrigue Surgical, Inc.
More Information
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Responsible Party: ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01733667    
Other Study ID Numbers: CSA2011-01
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by ENTrigue Surgical, Inc.:
synechia
Fess
sinus surgery