TerminatedPhase 4

Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

United States30 participantsStarted 2007-10

Plain-language summary

The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms.

Who can participate

Age range

6 Years – 17 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

. Patient is \>=6 and \<=17 years old.
. Patient has had symptoms of nasal obstruction for \>=6 months.
. Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documented maximum medical management (as described in Section 4.1).
. Patient has bilateral hypertrophied inferior turbinates without other abnormalities contributing to nasal obstruction (by nasal evaluation and examination).
. Patient and parent /guardian agree to participate in the clinical study and to complete all required visits and evaluations.
. Patient (or guardian) must sign IRB approved informed consent form.

Exclusion criteria

. Patient has clinically significant identifiable structural deformities other than turbinate hypertrophy that may contribute to nasal or upper airway obstruction including:
. Septal deviation
. Concha bullosa
. Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)

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

Change in nasal obstruction symptoms at 6-weeks post surgery as measured using a validated health-related quality of life questionnaire (SN5) compared to nasal obstruction symptoms measured before surgery using the same questionnaire.

Timeframe: 6 weeks, 6 months, 12 months

Trial details

NCT IDNCT00737906

SponsorArthroCare Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

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