Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRE System | Device | Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Visual Analog Scale (VAS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | ||||
| Vilnius University Hospital Santaros Klinikos |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
Not provided
Not provided
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction
Not provided
Not provided
Not provided
Not provided
|
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 |
| Vilnius |
| 08661 |
| Lithuania |
| Saint Mary Hospital | Bucharest | 011172 | Romania |
| Republican Specialized Scientific and Practical Medical Center for Otorhinolaryngology and Head and Neck Diseases | Tashkent | Yashnabad District | Uzbekistan |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |