Trials / Completed
CompletedNCT06438185
Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy
Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- ENTire Medical Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IRE System | Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction. |
Timeline
- Start date
- 2024-03-07
- Primary completion
- 2025-06-27
- Completion
- 2025-06-27
- First posted
- 2024-05-31
- Last updated
- 2026-03-17
Locations
4 sites across 4 countries: Israel, Lithuania, Romania, Uzbekistan
Source: ClinicalTrials.gov record NCT06438185. Inclusion in this directory is not an endorsement.