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

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

Tracking Information

• First Submitted Date: November 21, 2012
• First Posted Date: November 27, 2012
• Last Update Posted Date: June 5, 2013
• Study Start Date: December 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Synechia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 26, 2012): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01733667
• Other Study ID Numbers: CSA2011-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ENTrigue Surgical, Inc.
• Study Sponsor: ENTrigue Surgical, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ENTrigue Surgical, Inc.
• Verification Date: June 2013