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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.

Tracking Information
First Submitted Date  ICMJE November 21, 2012
First Posted Date  ICMJE November 27, 2012
Last Update Posted Date June 5, 2013
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Official Title  ICMJE A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Brief Summary The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Synechia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: MediENT
    Right or left sinus cavity where MediENT will be place after randomization.
    Intervention: Device: MediENT
  • Active Comparator: MeroPack
    Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.
    Intervention: Device: MeroPack
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01733667
Other Study ID Numbers  ICMJE CSA2011-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ENTrigue Surgical, Inc.
Study Sponsor  ICMJE ENTrigue Surgical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ENTrigue Surgical, Inc.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP