A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
2026年8月31日 更新者：Intuitive Surgical
A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).
調査の概要
状態
募集
詳細な説明
CT-guided percutaneous biopsy and ssRAB with CBCT are two types of lung nodule biopsy procedures routinely used in clinical practice. The study is designed to evaluate the diagnostic efficacy and safety of ssRAB with CBCT compared with CT-guided percutaneous lung nodule biopsy in adults requiring diagnostic evaluation of a pulmonary nodule. The co-primary objectives are to assess non-inferiority of diagnostic efficacy and superiority of safety.
The primary endpoints are diagnostic efficacy and the rate of peri-procedural pneumothorax (with or without intervention) associated with the assigned biopsy approach.
Eligible participants will be randomized 1:1 to either ssRAB with CBCT or CT-guided percutaneous lung nodule biopsy. If the clinical team determines that the assigned procedure is not suitable, the participant will receive the most appropriate standard of care instead. Both biopsy procedures will be performed according to routine clinical practice, and no experimental devices or procedures will be used.
Participants will be followed for up to 12 months through medical record review and routine clinical follow-up. Patient-reported quality of life and, optionally, work status will be assessed using questionnaires at multiple time points. No research-specific assessments, burdensome tests, or advanced imaging outside of standard care will be performed. A chest X-ray will be required following the biopsy procedure, consistent with routine clinical practice.
研究の種類
介入
入学 (推定)
550
段階
- フェーズ 4
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：Carine Van den Abeele
- 電話番号：+41 21 821 2000
- メール：Encompass@intusurg.com
研究連絡先のバックアップ
- 名前：Martha Bean
- 電話番号：+41 21 821 2000
- メール：Encompass@intusurg.com
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:
- Patient is aged 18 years or older at time of consent.
- Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent).
- Target pulmonary nodule ≤2 cm in largest diameter.
- Patient is willing and able to give written informed consent for clinical study participation.
Exclusion Criteria:
- Patient has previously undergone a biopsy procedure of the target nodule by any approach.
- Patient was previously randomized in this study but did not undergo biopsy.
- Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
- Patient is pregnant or breastfeeding as determined by standard site practices.
- Patient lacks the capacity to provide informed consent for themselves, or is a vulnerable patient whose ability to protect their own interests or to consent freely may be diminished, including but not limited to, patients who may be unduly influenced through dependency on the sponsor, the hospital, or the study doctor.
- Patient is not willing to comply with study participation requirements.
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：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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アクティブコンパレータ：Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
Participants randomized to pulmonary nodule biopsy using shape-sensing robotic-assisted bronchoscopy with cone-beam CT.
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A bronchoscopic lung nodule biopsy procedure performed using shape-sensing robotic-assisted bronchoscopy with cone-beam CT guidance as clinically indicated and according to standard clinical practice.
他の名前：
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アクティブコンパレータ：CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
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A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
他の名前：
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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 |
|---|---|---|
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Diagnostic Efficacy of the Assigned Biopsy Procedure
時間枠：At the index procedure
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Diagnostic efficacy will be calculated as the proportion of patients who receive their assigned treatment multiplied by diagnostic yield of their assigned treatment.
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At the index procedure
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Peri-Procedural Pneumothorax Rate
時間枠：From procedure to 7 days (or until subsequent intervention, whichever occurs first).
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Rate of peri-procedural pneumothorax related to the assigned index biopsy procedure, including pneumothorax identified on routine post-procedure imaging and clinically relevant pneumothorax requiring intervention or escalation of care.
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From procedure to 7 days (or until subsequent intervention, whichever occurs first).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diagnostic Yield
時間枠：At the index procedure
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Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance
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At the index procedure
|
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Sensitivity for Malignancy
時間枠：Through 1 year post-procedure
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Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up
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Through 1 year post-procedure
|
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Negative Predictive Value
時間枠：Through 1 year post-procedure
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Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up
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Through 1 year post-procedure
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Diagnostic accuracy
時間枠：Through 1 year post-procedure
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Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up.
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Through 1 year post-procedure
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Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing
時間枠：At the index procedure
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Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing.
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At the index procedure
|
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Procedure-Related Adverse Events
時間枠：Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
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Incidence of procedure-related adverse events.
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Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
|
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Procedure-related serious adverse events.
時間枠：Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
|
Incidence of procedure-related serious adverse events.
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Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
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All-Cause Mortality
時間枠：Through study exit
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Incidence of all-cause mortality among study participants.
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Through study exit
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Length of Stay for Procedure-Related Adverse Events
時間枠：From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure
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Duration of hospitalization attributable to procedure-related adverse events
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From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure
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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：Ricky Thakrar, MD、University College London Hospitals
- 主任研究者：Neal Navani, MD、University College London Hospitals
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)
2026年8月28日
一次修了 (推定)
2028年4月30日
研究の完了 (推定)
2029年4月30日
試験登録日
最初に提出
2026年7月30日
QC基準を満たした最初の提出物
2026年8月10日
最初の投稿 (実際)
2026年8月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月2日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年8月1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
- ISI-RCT-EU4-2025
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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