CompletedNot Applicable

Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

United States18 participantsStarted 2009-04

Plain-language summary

The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery. * Subject is able to provide a signed informed consent form. * Subject will agree to comply with all study-related procedures. * Subject is not pregnant at this time by confirmation of one of the following: * Subject is male * Subject not of child bearing age * Subject is surgically sterile * Subject is not pregnant per negative hCG test * Subject does not plan on becoming pregnant and is not breast feeding during the course of the study. Exclusion Criteria: * Subject does not meet inclusion criteria. * Presence of non-viable tissue at the implantation site. * History of septal perforation. * History of polyps. * Presence of concha bullosa. * Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea. * Subject is participating in a clinical trial which could affect the healing of the middle turbinate. * Subject has uncontrolled diabetes. * Subject is a: * smoker * severe drug abuser * severe alcohol abuser * Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional performance of the MTI

Timeframe: 1 month

Trial details

NCT IDNCT00896883

SponsorENTrigue Surgical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

View on ClinicalTrials.gov More Sinusitis trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.