A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
2026년 8월 31일 업데이트: 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).
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
550
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Carine Van den Abeele
- 전화번호: +41 21 821 2000
- 이메일: Encompass@intusurg.com
연구 연락처 백업
- 이름: Martha Bean
- 전화번호: +41 21 821 2000
- 이메일: Encompass@intusurg.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
|
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.
다른 이름들:
|
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic Efficacy of the Assigned Biopsy Procedure
기간: At the index procedure
|
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
기간: 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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic Yield
기간: At the index procedure
|
Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance
|
At the index procedure
|
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Sensitivity for Malignancy
기간: Through 1 year post-procedure
|
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
기간: Through 1 year post-procedure
|
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
기간: 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
기간: 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
기간: 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.
기간: 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 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
기간: Through study exit
|
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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ricky Thakrar, MD, University College London Hospitals
- 수석 연구원: Neal Navani, MD, University College London Hospitals
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 28일
기본 완료 (추정된)
2028년 4월 30일
연구 완료 (추정된)
2029년 4월 30일
연구 등록 날짜
최초 제출
2026년 7월 30일
QC 기준을 충족하는 최초 제출
2026년 8월 10일
처음 게시됨 (실제)
2026년 8월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 31일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ISI-RCT-EU4-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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예
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