ENTire Medical Ltd.
This study is a prospective, multi-center, single-arm study of pediatric subjects (age 3-12) with Sleep-Disordered Breathing ("SDB") due to adeno-tonsillar hypertrophy which are treated with the ENTire IRE System. Subjects will be followed for six (6) months post-treatment. The objective of the study is to provide an ongoing safety and effectiveness assessment of the ENTire IRE System in treating pediatric adeno-tonsillar hypertrophy.
Inclusion Criteria: * Patients are 3-12 years of age. * Tonsillar hypertrophy of grade 2 or more on the Brodsky Grading System for Tonsils ("BGST"). * Children with SDB scheduled for adeno-tonsillar surgery after an otolaryngology evaluation. Exclusion Criteria: 1. Patients with a pacemaker, cochlear or similar electro stimulator implants. 2. Patients for whom the anesthesia involves high risk. 3. Significant illness (e.g., cancer, severe autoimmune disease, neurological disease, severe heart disease). 4. Craniofacial anomalies. 5. Patients which underwent prior tonsillectomy or tonsillotom…
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 handpiece causing irreversible cell membrane perforation and apoptosis resulting in tissue reduction. The clinical effect is anticipated within 2 to 4 weeks post-treatment.
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