Inferior Turbinate Hypertrophy, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane
Conditions
Brief 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.
Detailed description
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 tonsil volume. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in interior turbinate reduction.
Interventions
DEVICEIRE System
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.
Sponsors
ENTire Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE) | 3 months post treatment | A change of \> 20% in Nasal Obstruction Symptom Evaluation Scale scale and a \> 20% in the Nasal Obstruction VAS score as compared to screening visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Sinonasal Outcome Test (SNOT-22) score | 3 months post treatment | A Sinonasal Outcome Test (SNOT-22) score improvement by at least a 8.9 point reduction at 3 months post treatment. |
| Pain Visual Analog Scale (VAS) | up to 1 week post treatment and through study subject completion | Low to moderate Pain VAS (VAS/Pain VAS) score (1-3 on a VAS Scale) post treatment. |
Countries
Israel, Lithuania, Romania, Uzbekistan
Outcome results
None listed