Inferior Turbinate HypertrophyNCT06438185
Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy
A study testing IRE System in people with Inferior Turbinate Hypertrophy and Nasal Obstruction, run by ENTire Medical Ltd. at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inferior Turbinate Hypertrophy, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane
- What is being tested?
- IRE System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 7 Mar 2024to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Lithuania1 site
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Uzbekistan1 site
Republican Specialized Scientific and Practical Medical Center for Otorhinolaryngology and Head and Neck Diseases
Tashkent, Yashnabad District
About this study
Official title: Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
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.
Read the 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.
- Being tested
- IRE System
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE SystemDevice
Also called ENtire IRE System
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IRE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post treatment
Secondary outcomes (2)
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.
Measured: 3 months post treatment
Pain Visual Analog Scale (VAS)
Low to moderate Pain VAS (VAS/Pain VAS) score (1-3 on a VAS Scale) post treatment.
Measured: up to 1 week post treatment and through study subject completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start7 Mar 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Turbinate HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENTire Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438185
- Sponsor's protocol ID
- CLN 0157
- Status last verified
- Mar 2026
- First submitted
- 23 May 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
- ClinicalTrials.gov ID
- NCT06438185
- Acronym / sponsor ID
- CLN 0157
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ENTire Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction
| Arm | Type | Receives |
|---|---|---|
| Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. | Experimental | Device: IRE SystemThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRE SystemAlso: ENtire IRE SystemIrreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction. | Device | Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. |
Primary outcome
Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)
Time frame: 3 months post treatment
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.
2 secondary outcomes
A Sinonasal Outcome Test (SNOT-22) score
Time frame: 3 months post treatment
Pain Visual Analog Scale (VAS)
Time frame: up to 1 week post treatment and through study subject completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Inferior Turbinate Hypertrophy
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Recruiting
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
Allergic Rhinitis
Active, not recruiting
Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis
Nasal Obstruction, Chronic Rhinitis
Recruiting
Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRE System in people with Inferior Turbinate Hypertrophy and Nasal Obstruction, run by ENTire Medical Ltd. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, Lithuania, Romania, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE) (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.