Management of Complex Airway Stenoses With Dedicated Tailored Stents Wrought by 3D Computer-assisted Conception (DASCAS)
Management of complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception
Dedicated Airway Stents for Central Airway Stenoses
DASCAS
Toulouse University Hospital is the sponsor of this research.
This research will be conducted with the support of AnatomikModeling and ADERSPOT
- Background: Tracheobronchial stent are devices designed to manage central airway stenoses of various origins. Their shape and sizes are however not suitable for stenosis of complex anatomy.
- Purpose: The investigators propose to test the feasibility and safety of treating complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception
Abstract: Central airway obstruction is currently managed with non-personalized stents, which are usually efficient but lead to severe and potentially lethal complications in 10% of cases (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem particularly unsuited for anatomically complex stenosis.
Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically improve the tolerance and safety of such prostheses.
This first feasibility study, dedicated to patients suffering from anatomically complex stenosis will test the safety of treating patients with these new approach. It should lead to larger studies evaluating these new types of stents in larger indications.
After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the same terms as pre-existing models.
Close follow up is then conducted, including clinical evaluation after one week, three and six months; spirometry at one week and 6 months and chest CT-scan at one week.
調査の概要
詳細な説明
Study design: Prospective monocentric feasibility study
Arm number or label and arm type: Only one experimental arm
Interventions:
After signature of a informed consent
Collection of clinical data (age, sex, etiology, site and mechanism of the stenosis, previous treatments dyspnea, quality of life (VQ11 questionnaire))
Chest CT-scan without contrast under continuous positive pressure
Spirometry (peak flow, FEV1)
Computer-assisted modelization of the shape of the prosthesis using 3D reconstruction of CT-scan
Machining of the shape in Ertacetal® (AnatomikModeling®)
Fabrication and sterilization of the stent in silicon (Sebbin®)
Insertion of the stent under rigid bronchoscopy and general anesthesia
Clinical follow-up at one week, 3 months and 6 months
Chest CT-scan without contrast at 1 week, spirometry at 1 week and 6 months
Number of subjects : 10 patients
Statistical analysis:
For the primary outcome, percentages of procedures conducted without complication at 1 week, 3 months, and 6 months and their confidence interval at 95% and incidences at 1 week, 3 months and 6 months for each complication will be calculated.
For secondary outcomes:
- Percentages of procedures conducted with improvement of dyspnea (improvement of at least one point of NYHA score) at 1 week, 3 months, and 6 months and their confidence interval at 95% will be calculated.
- Percentages of procedures conducted with improvement of quality of life (improvement of at least 10% of VQ11 score) at 1 week, 3 months, and 6 months and their confidence interval at 95% will be calculated.
- Percentages of procedures conducted with improvement of functional parameters (improvement of at least 20% of DEP or FEV1) at 1 week and 6 months and their confidence interval at 95% will be calculated.
- Percentage of procedures conducted with radiologic congruence of the stent at 1 week and its confidence interval at 95% will be calculated.
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Age > 18 years
- Signature of the informed consent form
- Patient with a complex upper airway stenosis .
- Symptomatic stenosis ( Dyspnea > NYHA II , cough, PEF < 50%)
- Stenosis whose complex anatomy does not allow the establishment of a currently available stent on the market: the assessment of the experts ( consensus decision between 3 bronchoscopistes of interventional endoscopy service) or after failure of one or several models.
- Affiliated with a social security scheme
Exclusion Criteria:
- Indication of implementation of emergency aid : signs of acute respiratory distress , PEF < 20 % predicted , SpO2 oxygen saturation <90 % on room air
- Contraindication to rigid bronchoscopy (severe coagulation disorders not correct )
- Patient under legal protection system
- Pregnancy
- Breastfeeding
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：new 3D device
dedicated tailored stents wrought by 3D computer-assisted conception
|
dedicated tailored stents wrought by 3D computer-assisted conception
|
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 of percentage of procedures conducted without complications at 1 week , 3 months and 6 months
時間枠：Change of percentage of procedures conducted without complications at 1 week, 3 months and 6 months
|
percentages of procedures conducted without complication at 1 week, 3 months and 6 month and their confidence interval at 95% and incidences at 1 week, 3 months and 6 months for each complication will be calculated.
|
Change of percentage of procedures conducted without complications at 1 week, 3 months and 6 months
|
協力者と研究者
捜査官
- 主任研究者：Nicolas Guibert, Dr、University Hospital, Toulouse
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
閉塞性気道疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
new 3D deviceの臨床試験
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