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:
ENTrigue Surgical, Inc.
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
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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:
|
|
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:
- Subject is between the ages of 18 and 65 years
- Subject scheduled to undergo bilateral endoscopic sinus surgery
- Subject signs IRB-approved informed consent form
- Subject agrees to comply with all study-related procedures
Exclusion Criteria:
- History of removal of one or both middle turbinates
- Significant sinonasal polyps
- Presence of marked septal asymmetry
- Presence of significant concha bullosa, which requires surgical excision
- Presence of non-viable tissue at the implantation site
- Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
- Known or suspected allergy to device components
- Participating in another clinical trial which could affect the healing of the middle turbinate
- Uncontrolled diabetes
- Known or suspected use of illicit drugs
- Known or suspected alcoholism
- Other medical illness that could prevent follow-up or increase the risk of surgery
- Pregnant or unwilling to take pregnancy prevention measures
- Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea
Contacts and Locations
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 June 17, 2013