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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Colorado
-
Denver、Colorado、アメリカ、80045
- Children's Hospital Colorado
-
-
Texas
-
Dallas、Texas、アメリカ、75390
- UT Southwestern Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events (Bleeding, Readmission, Dehydration, or Emergency Department Visit)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CLN 0330
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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