CompletedNot Applicable

Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy

Israel, Lithuania, Romania48 participantsStarted 2024-03-07

Plain-language summary

The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of the inferior turbinate volume.

Who can participate

Age range

18 Years – 70 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: * Age 18 - 70 years. * Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at the Baseline. * Hypertrophy of the inferior turbinate is the primary cause of the patient's nasal obstruction based on vasoconstriction test. * Did not improve with medical treatment, including topical nasal steroids for nasal obstruction for at least three months. Exclusion Criteria: * Age below 18 years * Patients with a pacemaker or similar electro stimulator * Patients with caudal septal deviation that narrows the anterior nasal valve. * Patients with nasal polyps/tumors. * Patients with chronic rhinosinusitis. * Patients with Eosinophilia * Patients for whom the anesthesia involves high risk. * Patients with Epilepsy or other condition involving convulsions. * Patients with an inability to give informed consent and to complete self-reported questionnaires. * Patients with an inability to cooperate for treatment and follow-up. * Patients with severe heart disease. * Pregnancy or breastfeeding. * Previous inferior turbinate surgery.

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

Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)

Timeframe: 3 months post treatment

Trial details

NCT IDNCT06438185

SponsorENTire Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-27

View on ClinicalTrials.gov More Inferior Turbinate Hypertrophy trials