Clinical trial · Observational
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
NCT04182815CI-TRIAL-00086601TARGETcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.
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 | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic assisted bronchoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Robotic assisted bronchoscopy
- description
- Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.
- interventionNames
- Device: Robotic assisted bronchoscopy
Primary outcomes (1)
- measure
- Incidence of device or procedure related complications
- timeFrame
- up to 7 days post procedure
- description
- The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale.
Secondary outcomes (9)
- measure
- Rate of device or procedure related complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Over 21 years of age; 2. Capable and willing to give informed consent; 3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure; 4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy Exclusion Criteria: 1. Medical contraindication to bronchoscopy as assessed by the investigator 2. Presence of uncorrectable bleeding disorders 3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker 4. Patients with the target lesion having endobronchial involvement seen on chest CT 5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, 6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study; 7. Uncontrolled or irreversible coagulopathy; 8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure; 9. CT scan done greater than 28 days before the bronchoscopy procedure.
References
Publications (3)
- DERIVEDGomes C, Cowan B, Xiao M, Morris P, Pederson D, Yasufuku K. Diagnostic effectiveness and safety of robotic-assisted bronchoscopy for subsolid pulmonary nodules: A multicenter prospective observational study. J Thorac Cardiovasc Surg. 2025 Oct;170(4):945-954. doi: 10.1016/j.jtcvs.2025.05.021. Epub 2025 Jun 7. PMID 40490212
- DERIVEDMurgu S, Chen AC, Gilbert CR, Sterman DH, Pederson D, Rafeq S, Laxmanan B, Schwiers ML, Connelly J, Benz HL, Yasufuku K, Silvestri GA; TARGET Investigators. A Prospective, Multicenter Evaluation of Safety and Diagnostic Outcomes With Robotic-Assisted Bronchoscopy: Results of the Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET) Trial. Chest. 2025 Aug;168(2):539-555. doi: 10.1016/j.chest.2025.04.022. Epub 2025 Apr 27. PMID 40300665
- DERIVEDAgrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344. PMID 33590989