Clinical trial · Interventional
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
NCT07761351CI-TRIAL-00125398ENCOMPASSrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Nodule | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-guided percutaneous lung nodule biopsy | Procedure | — | UNRESOLVED |
| Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
- description
- Participants randomized to pulmonary nodule biopsy using shape-sensing robotic-assisted bronchoscopy with cone-beam CT.
- interventionNames
- Procedure: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
- type
- ACTIVE_COMPARATOR
- label
- CT-Guided Percutaneous Lung Nodule Biopsy
- description
- Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
- interventionNames
- Procedure: CT-guided percutaneous lung nodule biopsy
Primary outcomes (2)
- measure
- Diagnostic Efficacy of the Assigned Biopsy Procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is aged 18 years or older at time of consent. 2. Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent). 3. Target pulmonary nodule ≤2 cm in largest diameter. 4. Patient is willing and able to give written informed consent for clinical study participation. Exclusion Criteria: 1. Patient has previously undergone a biopsy procedure of the target nodule by any approach. 2. Patient was previously randomized in this study but did not undergo biopsy. 3. 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. 4. Patient is pregnant or breastfeeding as determined by standard site practices. 5. 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. 6. Patient is not willing to comply with study participation requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.