Tonsillar Hypertrophy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIRE System
Irreversible Electroporation (IRE) System for Tonsil Reduction for the Treatment of Chronic Symptomatic Tonsillar Hypertrophy
Sponsors
ENTire Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 70 years. * Tonsillar Hypertrophy of grade 2 or higher on the Brodsky Grading Scale for Tonsils (BGST).
Exclusion criteria
* Age below 18 years. * Patients with a pacemaker or similar electro stimulator. * Patients for whom the anesthesia involves high risk. * Epilepsy or other condition involving convulsions. * Inability to give informed consent and to complete self-reported questionnaires. * Patients with an inability to cooperate for treatment and follow-up. * Severe heart disease. * Pregnancy or breastfeeding. * Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease). * Bleeding diathesis. * Patients suffering from obesity as indicated by a body mass index (BMI) \> 32kg/m2. * Known or suspected complications for any general or local anesthetic agents and/or any antibiotic medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Tonsil(s) Size at 3 Months Compared to the Baseline. | Baseline and 3 months post-treatment | 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). |
| Pain VAS Score at 1-week Post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Snore VAS at 3-months Post-treatment Compared to Baseline | Baseline and 3 months post-treatment | 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. |
| Number of Participants With Complications Including Bleeding | During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment. | 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. |
Countries
Romania
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 12.7 |
| Race/Ethnicity, Customized Caucasian | 24 Participants |
| Region of Enrollment Romania | 24 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 11 Participants |
| Snore Visual Analog Scale (VAS) | 10.43 Scores on a scale STANDARD_DEVIATION 8.27 |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Left Tonsil Grade 0 | 0 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Left Tonsil Grade 1 | 0 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Left Tonsil Grade 2 | 15 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Left Tonsil Grade 3 | 5 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Left Tonsil Grade 4 | 4 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Right Tonsil Grade 0 | 0 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Right Tonsil Grade 1 | 0 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Right Tonsil Grade 2 | 16 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Right Tonsil Grade 3 | 4 Participants |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST)) Right Tonsil Grade 4 | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
None listed