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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80045
- Children's Hospital Colorado
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events (Bleeding, Readmission, Dehydration, or Emergency Department Visit)
Tidsram: 6 months
|
Evaluation of the following device and/or procedure-related events: bleeding, readmission, dehydration and emergency department visits. |
6 months
|
|
Time From Treatment to First Wong-Baker FACES Pain Scale Score of 2 or Below
Tidsram: 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
Tidsram: 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
|
|
Change From Baseline in OSA-18 Total Score at 6 Months
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CLN 0330
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