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

Not Applicable

Completed

• Conditions: Synechia
• Interventions: Device: MediENT; Device: MeroPack

• Registration Number: NCT01733667
• Lead Sponsor: ENTrigue Surgical, Inc.

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MediENT	MediENT	Right or left sinus cavity where MediENT will be place after randomization.
MeroPack	MeroPack	Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.

Primary Outcome Measures

Name	Time	Method
Miller synechia score at 8 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Miller Score at 4 & 8 weeks	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

Trial Locations

Locations (5)

Colorado ENT & Allergy; 🇺🇸 Colorado Springs, Colorado, United States

ENT Associates of Texas; 🇺🇸 McKinney, Texas, United States

Central California ENT Medical Group; 🇺🇸 Fresno, California, United States

Advanced ENT and Allergy; 🇺🇸 Louisville, Kentucky, United States

Ear, Nose & Throat Clinics of San Antonio; 🇺🇸 San Antonio, Texas, United States