A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 3
- 主要终点
- Diagnostic Efficacy of the Assigned Biopsy Procedure
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
干预措施: CT-guided percutaneous lung nodule biopsy (Procedure)
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.
干预措施: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT) (Procedure)
结局指标
主要结局
Diagnostic Efficacy of the Assigned Biopsy Procedure
时间窗: 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.
Peri-Procedural Pneumothorax Rate
时间窗: From procedure to 7 days (or until subsequent intervention, whichever occurs first).
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.
次要结局
- All-Cause Mortality(Through study exit)
- Sensitivity for Malignancy(Through 1 year post-procedure)
- Diagnostic Yield(At the index procedure)
- Negative Predictive Value(Through 1 year post-procedure)
- Diagnostic accuracy(Through 1 year post-procedure)
- Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing(At the index procedure)
- Procedure-Related Adverse Events(Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first)
- Procedure-related serious adverse events.(Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first)
- Length of Stay for Procedure-Related Adverse Events(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)