Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis (BREATHE AI)
Quantitative Evaluation of Nasal Airway Remodeling Following Temperature-Controlled Radiofrequency Treatment for Nasal Airway Obstruction Using AI-Assisted Analysis (BREATHE AI)
The goal of this clinical trial is to measure changes in the nasal airway after treatment with the VivAer® procedure in adults aged 22 to 85 with nasal airway obstruction caused by nasal valve dysfunction. The main questions it aims to answer are:
Are there measurable changes in the nasal airway and airflow after treatment with the VivAer procedure?
Participants will:
Undergo the VivAer procedure, which uses radiofrequency energy to remodel tissue in the nasal valve area. Have endoscopic images of their nasal airway taken before treatment and at follow-up visits at 3 and 6 months after treatment, which will be analyzed using the VISIONAIR™ AI System. They will complete symptom and quality of life surveys at each visit, including the Nasal Obstruction Symptom Evaluation (NOSE) Scale, the STOP-BANG Sleep Score, and the Short-Form (SF-12) Health Survey.
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
研究連絡先
- 名前：Neda Haque
- 電話番号：(408) 784-9452
- メール：nhaque@aerinmedical.com
研究連絡先のバックアップ
- 名前：Tien Dang
- メール：tdang@aerinmedical.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 22 to 85 years old (inclusively).
- Willing and able to provide consent.
- Willing and able to comply with the patient-specific requirements and follow-up schedule outlined in the study protocol.
- Has a NOSE Score of ≥ 55.
- Has a documented diagnosis of NAO with NVC (static or dynamic) as the primary driver of NAO symptoms.
- Has a documented positive Modified Cottle Maneuver (using curette or equivalent to perform maneuver and evaluate nasal valve function).
Exclusion Criteria:
- Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
- Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
- Has a complex nasal anatomy (e.g., anatomical deformity) or a history of significant nasal trauma that is a potential contributor to nasal obstruction symptoms.
- Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
- Has a medical condition(s) that may impair normal healing processes.
- Any adjunctive surgical or other nasal procedure (e.g., concha bullosa resection, inferior turbinate out fracture, septoplasty, etc.) on the same day or planned within 6 months of the study procedure.
- Has current or recent (within 30 days prior to screening) exposure to oral systemic corticosteroids or is expected to require oral corticosteroid therapy during the course of the study.
- Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.
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 |
|---|---|
|
他の：VivAer Treatment
|
Bipolar radiofrequency energy delivered to the lateral nasal wall at the upper lateral cartilage using the VivAer® Stylus and Aerin Console at device default settings (temperature 60°C, power 4 watts, treatment time 18 seconds, cooling time 12 seconds) to remodel submucosal tissue, including cartilage, in the internal nasal valve area.
|
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 |
|---|---|---|
|
Change in nasal valve angle and cross-sectional area
時間枠：Baseline to 3- and 6-months post-procedure.
|
Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIR™ analysis.
|
Baseline to 3- and 6-months post-procedure.
|
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
キーワード
その他の研究ID番号
- CTP2527
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?
IPD プランの説明
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。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。