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

NCT01733667 | Completed

• 1 other identifier: CSA2011-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Synechia

Keywords

synechia; Fess; sinus surgery

Outcome Measures

Primary Outcomes (1)

• Miller synechia score at 8 weeks

  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)

  8 weeks post endoscopic sinus surgery

Secondary Outcomes (1)

• Miller Score at 4 & 8 weeks

  4 & 8 weeks post endoscopic sinus surgery

Study Arms (2)

MediENT

EXPERIMENTAL

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

Device: MediENT

MeroPack

ACTIVE COMPARATOR

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

Device: MeroPack

Interventions

MediENT DEVICE

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

Also known as: MeroPack

MediENT

MeroPack DEVICE

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

MeroPack

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ENTrigue Surgical, Inc.: lead

Study Sites (5)

Central California ENT Medical Group

Fresno, California, 93720, United States

Location

Colorado ENT & Allergy

Colorado Springs, Colorado, 80909, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

ENT Associates of Texas

McKinney, Texas, 75079, United States

Location

Ear, Nose & Throat Clinics of San Antonio

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (5)