Treatment for enlarged inferior turbinates causing nasal obstruction
Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
This study is testing a new noninvasive treatment for people with nasal obstruction caused by enlarged turbinates to see if it works better and is more comfortable than traditional options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ENTire Medical Ltd. Industry-sponsored |
| Locations | 3 sites (Tel Aviv and 2 other locations) |
| Trial ID | NCT06438185 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of the IRE System, a noninvasive treatment designed to reduce the volume of hypertrophic inferior turbinates that cause nasal obstruction. The IRE System utilizes a high voltage pulsed electric field to create irreversible nanopores in cell membranes, leading to cell death and a reduction in turbinate size. The study aims to determine how effective this method is compared to traditional treatments, particularly for patients who have not responded to medical therapies. The procedure is designed to be more comfortable and quicker than existing options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a significant nasal obstruction symptom score and hypertrophy of the inferior turbinates that has not improved with medical treatment.
Not a fit: Patients with conditions such as nasal polyps, chronic rhinosinusitis, or those who are pregnant may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve breathing and quality of life for patients suffering from nasal obstruction due to inferior turbinate hypertrophy.
How similar studies have performed: While the IRE System represents a novel approach, similar noninvasive techniques have shown promise in treating nasal obstruction, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tel Aviv and 2 other locations
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (Recruiting)
- Saint Mary Hospital — Bucharest, Romania (Active_not_recruiting)
Study contacts
- Study coordinator: Danielle Vales
- Email: Danielle@carbo-fix.com
- Phone: +972 0508881100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.