A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ENTrigue Surgical, Inc.
MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
