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

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

Detailed Description
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MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.

Official Title
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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

Conditions
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Synechia

Intervention / Treatment
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* Device: MediENT
* Device: MeroPack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MediENT<br>Right or left sinus cavity where MediENT will be place after randomization. | Device: MediENT<br>* 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<br>* Other names: MeroPack;|
| Active Comparator: MeroPack<br>Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned. | Device: MeroPack<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miller synechia score at 8 weeks | 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) | 8 weeks post endoscopic sinus surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miller Score at 4 & 8 weeks | 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 | 4 & 8 weeks post endoscopic sinus surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fess, sinus surgery, synechia