【米国FDAの承認または認可を受けていない機器の治験】
2026年4月25日 更新者：Aventix Medical Inc.
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
調査の概要
詳細な説明
The NOVOCLEAR™ Device is a radiofrequency-based hand-held device intended to treat chronic rhinitis by delivering pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. The NOVOCLEAR™ Device is used with the AVENTIX™ PFX System. The AVENTIX™ PFX System is a radiofrequency-based electrosurgical system designed to deliver non-thermal pulsed field energy to the targeted tissue.
This is a non-significant risk, prospective, multi-center, single arm study to evaluate the safety, effectiveness and tolerability of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：ClinicalAdmin
- 電話番号：(510) 912-2589
- メール：clinical@aventixmed.com
研究場所
-
-
Colorado
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Colorado Springs、Colorado、アメリカ、80923
- 募集
- Colorado ENT and Allergy
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主任研究者：
- Bryan Davis, MD
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コンタクト：
- Monica Davis
- 電話番号：(719) 867-7804
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Mississippi
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Ocean Springs、Mississippi、アメリカ、39564
- 募集
- Bay Area ENT
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コンタクト：
- Raymond Weiss, MD
-
-
Texas
-
San Antonio、Texas、アメリカ、78256
- 募集
- Atkins Expert Sinus Care
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コンタクト：
- James Atkins, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- The subject is 18 to 85 years of age.
- The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
- The subject has an rTNSS total score of ≥ 6.
- The subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion (rTNSS rating of 2 or 3 for rhinorrhea and 1, 2, or 3 for congestion)
- The subject is able and willing to provide written informed consent and comply with the protocol requirements.
Exclusion Criteria:
- The subject has clinically significant anatomic obstructions on either side that limit access to the posterior nose, including severe septal deviation, nasal polyps, and sinonasal tumor
- The subject has a septal perforation
- The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
- The subject had had previous surgery of the PNN for chronic rhinitis.
- The subject has had prior head or neck irradiation
- The subject has an active or chronic nasal or sinus infection
- The subject has active coagulation disorder, or the patient is receiving anticoagulants
- The subject has a history of dry eye or dry nose symptoms
- Patient has rhinitis medicamentosa
- The subject has ocular allergic symptoms
- The subject has a history of nose bleeds
- The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
- The subject is pregnant or lactating
- The subject is participating in another clinical research study
- The subject has an allergy or intolerance to anesthetic agent
- Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：NOVOCLEAR™ Device Treatment Group
Subjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
|
Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
|
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 |
|---|---|---|
|
Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.
時間枠：90 days
|
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Total scores range from 0 to 12.
A higher score indicates increased symptom severity.
|
90 days
|
|
Proportion of subjects with device and/or procedure-related serious adverse events through 90 days
時間枠：90 days
|
Characterization of the type and frequency of study device and/or study procedure-related adverse events reported during or following the study procedure through 90 days follow-up.
|
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean change in rTNSS at 7 days compared to baseline
時間枠：7 days
|
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Total scores range from 0 to 12.
A higher score indicates increased symptom severity.
|
7 days
|
|
Mean change in rTNSS at 14 days compared to baseline
時間枠：14 days
|
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Total scores range from 0 to 12.
A higher score indicates increased symptom severity.
|
14 days
|
|
Mean change in rTNSS at 30 days compared to baseline
時間枠：30 days
|
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Total scores range from 0 to 12.
A higher score indicates increased symptom severity.
|
30 days
|
|
Mean change in rTNSS at 6 months compared to baseline
時間枠：6 months
|
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Total scores range from 0 to 12.
A higher score indicates increased symptom severity.
|
6 months
|
|
Mean change in rTNSS at 1 year compared to baseline
時間枠：1 year
|
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Total scores range from 0 to 12.
A higher score indicates increased symptom severity.
|
1 year
|
|
Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure
時間枠：Post-procedure
|
Immediately after the study procedure, subjects will be asked to rate the pain they experienced in their nasal cavity(ies) during the procedure using a 100 mm visual analogue scale with 0 mm representing no pain and 100 mm representing worst pain imaginable.
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Post-procedure
|
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Subject satisfaction at 90 days
時間枠：90 days
|
Subjects will be asked two questions regarding their satisfaction with the study procedure. The first question asks; How satisfied with your procedure are you?; with the following five response options: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The second question asks; How likely are you to refer a friend for this procedure?; with the following five response options: very likely, likely, neutral, unlikely, or very unlikely. |
90 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Raymond Weiss, MD、Bay Area ENT
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年11月15日
一次修了 (推定)
2026年4月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2024年9月13日
QC基準を満たした最初の提出物
2024年9月13日
最初の投稿 (実際)
2024年9月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年4月30日
QC基準を満たした最後の更新が送信されました
2026年4月25日
最終確認日
2026年4月1日
詳しくは
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。