Clinical trial NCT06438185: Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy
Official title: Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inferior Turbinate Hypertrophy
Nasal Obstruction
Turbinate; Hypertrophy Mucous Membrane
Lead sponsor: ENTire Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)
timeFrame: 3 months post treatment
Secondary outcomes:
measure: A Sinonasal Outcome Test (SNOT-22) score
timeFrame: 3 months post treatment
measure: Pain Visual Analog Scale (VAS)
timeFrame: up to 1 week post treatment and through study subject completion
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Bucharest
country: Romania
facility: Saint Mary Hospital
Study officials:
References: