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

Completed · Not applicable

Conditions studied: Synechia

In brief

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

Key facts

Study ID

NCT01733667

Run by

ENTrigue Surgical, Inc.

People needed

60

Starts

2011-12-01

Expected to finish

2013-02-01

Last updated by the study team

2013-06-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central California ENT Medical Group — Fresno, California, United States
• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• ENT Associates of Texas — McKinney, Texas, United States
• Ear, Nose & Throat Clinics of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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