Pediatric Adeno-Tonsillar Hypertrophy Treatment Post-Approval Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Denver, Colorado, Estados Unidos, 80045
- Children's Hospital Colorado
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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:
- Patients with a pacemaker, cochlear or similar electro stimulator implants.
- Patients for whom the anesthesia involves high risk.
- Significant illness (e.g., cancer, severe autoimmune disease, neurological disease, severe heart disease).
- Craniofacial anomalies.
- Patients which underwent prior tonsillectomy or tonsillotomy.
- Epilepsy or other conditions involving convulsions.
- Parent/Guardian inability to give informed consent and to complete reported questionnaires.
- Any other reason the investigator deems the subject is unfit for participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events (Bleeding, Readmission, Dehydration, or Emergency Department Visit)
Periodo de tiempo: 6 months
|
Evaluation of the following device and/or procedure-related events: bleeding, readmission, dehydration and emergency department visits. |
6 months
|
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Time From Treatment to First Wong-Baker FACES Pain Scale Score of 2 or Below
Periodo de tiempo: From procedure until the end of the first week post procedure (7 days)
|
For each participant, the number of days from treatment until the first daily pain score of 2 or below on the Wong-Baker FACES® Pain Scale. Pain is assessed after treatment and then daily for the first 7 days post-procedure. The scale ranges from 0 ("No hurt") to 10 ("Hurts worst"). Minimum value is 0 and maximum value is 10; higher scores indicate more pain (a worse outcome). |
From procedure until the end of the first week post procedure (7 days)
|
|
Change From Baseline in OSA-18 Total Score at 3 Months
Periodo de tiempo: 3 months post treatment
|
The Obstructive Sleep Apnea-18 (OSA-18) questionnaire is completed by the parent or caregiver at baseline and at 3 months post treatment. The outcome is the change in OSA-18 total score from baseline to 3 months. The questionnaire has 18 questions, each rated from 1 ("None of the time") to 7 ("All of the time"). The total score ranges from 18 (minimum) to 126 (maximum); higher scores indicate more severe symptoms and greater impairment (a worse outcome). No formal hypothesis will be tested. |
3 months post treatment
|
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Change From Baseline in OSA-18 Total Score at 6 Months
Periodo de tiempo: 6 months post treatment
|
The Obstructive Sleep Apnea-18 (OSA-18) questionnaire is completed by the parent or caregiver at baseline and at 6 months post treatment. The outcome is the change in OSA-18 total score from baseline to 6 months. The questionnaire has 18 questions, each rated from 1 ("None of the time") to 7 ("All of the time"). The total score ranges from 18 (minimum) to 126 (maximum); higher scores indicate more severe symptoms and greater impairment (a worse outcome). No formal hypothesis will be tested. |
6 months post treatment
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CLN 0330
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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