Synechia
Conditions
Keywords
synechia, Fess, sinus surgery
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.
Interventions
DEVICEMediENT
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
DEVICEMeroPack
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
Sponsors
ENTrigue Surgical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed