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The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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.
The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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 tonsillar reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlarged tonsil(s) mass 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRE System | Device | Irreversible Electroporation (IRE) System for Tonsil Reduction for the Treatment of Chronic Symptomatic Tonsillar Hypertrophy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Tonsil(s) Size at 3 Months Compared to the Baseline. | Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) as assessed 3 months post-treatment compared to the Baseline assessment. BGST consists of a scale from 0 to 4, evaluating tonsil(s) airway obstruction based on the following grading system: Grade 0 denotes a complete absence of obstruction on the oropharyngeal airway (i.e. best). Grade 1 is defined as tonsil(s) that sit just outside of the tonsillar fossa with obstruction of less than 25% of the airway. Grade 2 Tonsil(s) are readily seen in the airway- 25 to 50% of the airway is obstructed. Grade 3 Tonsil(s) denote a 50 to 75% obstruction of the airway. Grade 4 represents Tonsil(s) involving a greater than 75% obstruction of the airway (worst). A negative outcome value indicates a reduction in Brodsky grade (tonsil size). | Baseline and 3 months post-treatment |
| Pain VAS Score at 1-week Post-treatment | Pain VAS score at 1-week follow-up; The Pain Visual Analog Scale ("Pain VAS") at 1-week follow-up visit assessed using a horizontal 10cm visual analog scale ranging from 0 "No Pain" to 10 "Worst Pain Imaginable". Scores are obtained by measuring the distance in cm from the left origin of the line (0) to the point indicated with a vertical mark placed by the participant to indicate their current level of pain. | 1-week post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Snore VAS at 3-months Post-treatment Compared to Baseline | Patient overall well-being was assessed using verified subject-reported Snore VAS at three months post-treatment compared to the baseline. The participants were asked to estimate the severity of their snoring using a 10 cm visual analogue scale (VAS) from 0 (no snoring/"Never") to 10 (very severe snoring/"All the time"). The total score is the sum of the scores of the three questions, for a total out of 30, with the minimum possible total score of 0 (no snoring/"Never") to 30 (very severe snoring/"All the time"). The mean change in subjective snoring severity Snore (VAS) at 3 months after treatment with IRE was the primary outcome measurement. A negative score indicates a reduction in snoring quality of life symptoms. A larger negative score is a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Mary Hospital | Bucharest | Romania |
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A total of 24 adults were enrolled into a single-arm trial. A total of 25 subjects were screened for the study; one subject did not meet the inclusion criteria following anesthesiology review.
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| ID | Title | Description |
|---|---|---|
| FG000 | ENTire IRE System Arm | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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During the study, 24 patients were screened and consented and enrolled in the study.
One patient withdrew from the study after the one-month post-procedure follow-up. This patient was still included in the intent-to-treat data analysis with the data obtained.
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| ID | Title | Description |
|---|---|---|
| BG000 | ENTire IRE System Arm | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Tonsil(s) Size at 3 Months Compared to the Baseline. | Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) as assessed 3 months post-treatment compared to the Baseline assessment. BGST consists of a scale from 0 to 4, evaluating tonsil(s) airway obstruction based on the following grading system: Grade 0 denotes a complete absence of obstruction on the oropharyngeal airway (i.e. best). Grade 1 is defined as tonsil(s) that sit just outside of the tonsillar fossa with obstruction of less than 25% of the airway. Grade 2 Tonsil(s) are readily seen in the airway- 25 to 50% of the airway is obstructed. Grade 3 Tonsil(s) denote a 50 to 75% obstruction of the airway. Grade 4 represents Tonsil(s) involving a greater than 75% obstruction of the airway (worst). A negative outcome value indicates a reduction in Brodsky grade (tonsil size). | One subject elected to withdraw from the study after completing the 1-month follow-up visit, and requested to undergo standard tonsillectomy. The withdrawal was not associated with any complications or safety concerns. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 months post-treatment |
Day 0 (after commencement of treatment with the ENTire IRE System) to 3 Months (+21 days) follow-up.
Definition of adverse event is consistent with clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENTire IRE System Arm | 24 Adult subjects undergoing treatment for hypertrophic tonsils. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Vales | ENTire Medical | 972-9-9511511 | info@ent-ire.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2023 | Mar 15, 2026 | Prot_SAP_000.pdf |
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Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
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| Baseline and 3 months post-treatment |
| Number of Participants With Complications Including Bleeding | The study safety and risk success was evaluated by device-related, intraoperative and postoperative serious adverse events and also through documented physical assessments of the incidence of post-treatment reactions. The presence and documentation of complications were assessed during treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment. | During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) | BGST consists of a scale from 0 to 4, evaluating tonsil(s) airway obstruction based on the following grading system: Grade 0 denotes a complete absence of obstruction on the oropharyngeal airway (i.e. best). Grade 1 is defined as tonsil(s) that sit just outside of the tonsillar fossa with obstruction of less than 25% of the airway. Grade 2 Tonsil(s) are readily seen in the airway- 25 to 50% of the airway is obstructed. Grade 3 Tonsil(s) denote a 50 to 75% obstruction of the airway. Grade 4 represents Tonsil(s) involving a greater than 75% obstruction of the airway (worst). | Count of Participants | Participants |
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| Snore Visual Analog Scale (VAS) | Snore Visual Analog Scale (Snore VAS) consists of three questions covering three categories; 1) frequency of snoring; 2) how much their snoring bothers them, 3) how much their snoring bothers their partner, if applicable. The participants were asked to estimate the severity of their snoring using a 10 cm visual analogue scale (VAS) from 0 (no snoring/"Never") to 10 (very severe snoring/"All the time"). The total score is the sum of the scores of the three questions, for a total out of 30. | Mean | Standard Deviation | Scores on a scale |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | ENTire IRE System Arm | 23 Adult subjects undergoing treatment for hypertrophic tonsils. |
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| Primary | Pain VAS Score at 1-week Post-treatment | Pain VAS score at 1-week follow-up; The Pain Visual Analog Scale ("Pain VAS") at 1-week follow-up visit assessed using a horizontal 10cm visual analog scale ranging from 0 "No Pain" to 10 "Worst Pain Imaginable". Scores are obtained by measuring the distance in cm from the left origin of the line (0) to the point indicated with a vertical mark placed by the participant to indicate their current level of pain. | Posted | Mean | Standard Deviation | score on a scale | 1-week post-treatment |
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| Secondary | Change in Snore VAS at 3-months Post-treatment Compared to Baseline | Patient overall well-being was assessed using verified subject-reported Snore VAS at three months post-treatment compared to the baseline. The participants were asked to estimate the severity of their snoring using a 10 cm visual analogue scale (VAS) from 0 (no snoring/"Never") to 10 (very severe snoring/"All the time"). The total score is the sum of the scores of the three questions, for a total out of 30, with the minimum possible total score of 0 (no snoring/"Never") to 30 (very severe snoring/"All the time"). The mean change in subjective snoring severity Snore (VAS) at 3 months after treatment with IRE was the primary outcome measurement. A negative score indicates a reduction in snoring quality of life symptoms. A larger negative score is a better outcome. | Patient overall well-being was assessed using verified subject-reported Snore VAS at three months post-treatment compared to the baseline. All patients completed the questionnaires. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 months post-treatment |
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| Secondary | Number of Participants With Complications Including Bleeding | The study safety and risk success was evaluated by device-related, intraoperative and postoperative serious adverse events and also through documented physical assessments of the incidence of post-treatment reactions. The presence and documentation of complications were assessed during treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment. | Posted | Count of Participants | Participants | During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment. |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| Grade 4 |
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