Clinical trial · Interventional
iNod™ Ultrasound-Guided Needle Biopsy System Study
Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses
NCT05804435CI-TRIAL-00074859withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy, Fine-Needle | — | UNRESOLVED | — |
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Solitary Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iNod™ System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iNod™ System
- description
- Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System
- interventionNames
- Device: iNod™ System
Primary outcomes (2)
- measure
- Proportion of patients where the needle is visualized by the iNOD system inside the lesion
- timeFrame
- Procedure
- description
- Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.
- measure
- Adverse Events
- timeFrame
- Procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 2. Subject willing and able to comply with study procedures and provide written informed consent to participate in study. 3. Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. If the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up at least 80% of the lesion. a. "Peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope. 4. Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject. Exclusion Criteria: 1. Subjects with pure ground glass opacity or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT. 2. Subjects who have medical contraindication to undergo conventional flexible or robotic bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator. 3. Subjects with known coagulopathy. 4. Subjects who are pregnant or nursing mothers. 5. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. 6. Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
References
Publications (0)
Data not yet available
No reference posted for this study.