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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT01733667
First received: November 21, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.


Condition Intervention
Synechia
Device: MediENT
Device: MeroPack

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ENTrigue Surgical, Inc.:

Primary Outcome Measures:
  • Miller synechia score at 8 weeks [ Time Frame: 8 weeks post endoscopic sinus surgery ] [ Designated as safety issue: No ]
    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:
  • Miller Score at 4 & 8 weeks [ Time Frame: 4 & 8 weeks post endoscopic sinus surgery ] [ Designated as safety issue: No ]
    • 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


Enrollment: 60
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • MediENT
  • 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733667

Locations
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

No publications provided

Responsible Party: ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01733667     History of Changes
Other Study ID Numbers: CSA2011-01
Study First Received: November 21, 2012
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ENTrigue Surgical, Inc.:
synechia
Fess
sinus surgery

ClinicalTrials.gov processed this record on October 23, 2014