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

E

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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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