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

Launched by ENTIRE MEDICAL LTD. · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method using an IRE System for patients who have problems with their inferior turbinates, which are structures inside the nose that can become enlarged and cause breathing difficulties. The goal of the trial is to see if this system can safely reduce the size of these turbinates, helping to relieve nasal obstruction while minimizing discomfort and side effects. The IRE System works by using a special electric field to target and reduce the volume of the turbinates without the need for invasive surgery.

To be eligible for the trial, participants need to be between 18 and 70 years old and have a specific score indicating significant nasal obstruction that hasn't improved with medical treatments like nasal sprays for at least three months. There are some health conditions that may prevent individuals from participating, such as having a pacemaker, certain types of nasal issues, or severe heart disease. Participants in the trial can expect to undergo a noninvasive procedure that aims to improve their breathing, and they will be closely monitored throughout the process to ensure their safety and comfort.

Gender

ALL

Eligibility 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.