A Prospective, Randomized, Multi-Center… | Clinical Trial

Key information

Conditions

Synechia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central California ENT Medical Group, Fresno, California, United States

About this study

MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other names: MeroPack

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

Primary outcomes

Miller synechia score at 8 weeks

Time frame: 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 outcomes

Miller Score at 4 & 8 weeks

Time frame: 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

Sponsors and collaborators

Lead sponsor

ENTrigue Surgical, Inc.

Industry

Registry information

Acronym: MISTY

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Nov 27, 2012
Registry last updated: Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.