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

Nasal Obstruction Clinical Trial

Official title:

Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438185
• Other study ID #: CLN 0157
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: March 2026

Study information

• Verified date: June 2024
• Source: ENTire Medical Ltd.
• Contact: Danielle Vales
• Phone: +972 0508881100
• Email: Danielle[@]carbo-fix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrophy
• Nasal Obstruction
• Turbinate; Hypertrophy Mucous Membrane

Intervention

Device:
• IRE System
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
ENTire Medical Ltd.

Countries where clinical trial is conducted

Israel,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)	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.	3 months post treatment
Secondary	A Sinonasal Outcome Test (SNOT-22) score	A Sinonasal Outcome Test (SNOT-22) score improvement by at least a 8.9 point reduction at 3 months post treatment.	3 months post treatment
Secondary	Pain Visual Analog Scale (VAS)	Low to moderate Pain VAS (VAS/Pain VAS) score (1-3 on a VAS Scale) post treatment.	up to 1 week post treatment and through study subject completion