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

ENTrigue Surgical

Status: Completed

Conditions: Synechia

Treatments: Device: MediENT; Device: MeroPack

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733667

CSA2011-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

MediENT

Experimental group

Description:

Right or left sinus cavity where MediENT will be place after randomization.

Treatment:

Device: MediENT

MeroPack

Active Comparator group

Description:

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

Treatment:

Device: MeroPack