Trial Outcomes & Findings for Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment (NCT NCT06187194)

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.

Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy 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 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.

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.

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.