## Protocol Section
### Identification Module
**NCT ID:** NCT06438185

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CLN 0157
#### Organization
**Class:** INDUSTRY
**Full Name:** ENTire Medical Ltd.
### Status Module
#### Completion Date
**Date:** 2026-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** ENTire Medical Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Inferior Turbinate Hypertrophy

- Nasal Obstruction

- Turbinate; Hypertrophy Mucous Membrane

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The bi-polar IRE System locally applies short, high-voltage (HV) pulses, increasing the permeability of tissue cells, creating non-thermal irreversible electroporation (NTIRE). The energy is transferred via bipolar forceps and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment.

**Intervention Names:**

- Device: IRE System

**Label:** Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System.

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System.

**Description:** Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.

**Name:** IRE System

**Other Names:**

- ENtire IRE System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** A reduction of \> 20% in Nasal Obstruction Symptom Evaluation Scale scale and a \> 20% in the Nasal Obstruction VAS score as compared to screening visit.

**Measure:** Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)

**Time Frame:** 3 months post treatment

#### Secondary Outcomes

**Description:** A Sinonasal Outcome Test (SNOT-22) score improvement 3 months post treatment.

**Measure:** A Sinonasal Outcome Test (SNOT-22) score

**Time Frame:** 3 months post treatment

**Description:** Low to moderate Pain VAS (VAS/Pain VAS) score post treatment.

**Measure:** Pain Visual Analog Scale (VAS)

**Time Frame:** up to 1 week post treatment and through study subject completion

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Danielle@carbo-fix.com

**Name:** Danielle Vales

**Phone:** +972 0508881100

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tel Aviv

**Contacts:**

***Contact 1:***

- **Email:** Navac@tlvmc.gov.il

- **Phone:** +972 03-6974444

- **Role:** CONTACT

**Country:** Israel

**Facility:** Tel Aviv Sourasky Medical Center

**Status:** RECRUITING

**Location 2:**

**City:** Vilnius

**Contacts:**

***Contact 1:***

- **Email:** info@santa.lt

- **Phone:** +370 852365010

- **Role:** CONTACT

**Country:** Lithuania

**Facility:** Vilnius University Hospital Santaros Klinikos

**Status:** NOT_YET_RECRUITING

**Zip:** 08661

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000000402

- Term: Airway Obstruction

- ID: D000012131

- Term: Respiratory Insufficiency

- ID: D000012120

- Term: Respiration Disorders

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophy

- ID: M18157

- Name: Nasal Obstruction

- Relevance: HIGH

- As Found: Nasal Obstruction

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3750

- Name: Airway Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015508

- Term: Nasal Obstruction

- ID: D000006984

- Term: Hypertrophy

### Misc Info Module

- Version Holder: 2024-05-31
