Clinical trial · Interventional
Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System
A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging
NCT05867953CI-TRIAL-00094715completedN/AClinicalTrials.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)
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. Data on safety will also be collected.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biopsy Arm
- description
- Patients undergoing biopsy with the Ion Endoluminal System
- interventionNames
- Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
Primary outcomes (1)
- measure
- Tool in Nodule
- timeFrame
- At time of the biopsy procedure (Day 0)
- description
- Rate of achieving biopsy tool position within the targeted nodule(s), documented by means of intraprocedural 3D imaging. Defined as how often the biopsy needle used to sample the tissue is positioned directly within the nodule before the sample is taken. If biopsy forceps are used, it is how often the instrument is surrounding the nodule before the sample is taken
Secondary outcomes (2)
- measure
- Diagnostic accuracy of sample(s) obtained
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. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion. 3. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan). 4. Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan. 5. Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention. 6. Patient is willing and able to give written informed consent for Clinical Investigation participation. 7. Patient is not legally incapacitated or in a legal/court ordered institution. Exclusion Criteria: 1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure. 2. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure. 3. Presence of mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan. 4. Patient with American Society of Anesthesiologists Classification (ASA) ≥4. 5. Patient underwent a pneumonectomy. 6. Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state. 7. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding. 8. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. 9. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. 10. Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation. 11. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation. 12. Patient is not willing to comply with post study procedure participation requirements.
References
Publications (1)
- DERIVEDChan LT, Lau KKW, Orton CM, Temov K, Tana A, Baboolal I, Karir A, Agaoglu E, Garner J, Kalyal A, Lapuente M, Ttofia F, Shah PL. Tool in lesion verification of shape-sensing robotic-assisted bronchoscopy with cone beam CT in sampling peripheral pulmonary nodules. Thorax. 2026 May 14;81(6):571-580. doi: 10.1136/thorax-2025-223631. PMID 41391887