Clinical trial · Interventional
Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
Safety and Feasibility of a Novel Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
- 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)
As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients
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 Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LungBrella marker implantation and VATS partial lobe resection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- LungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery
- interventionNames
- Device: LungBrella marker implantation and VATS partial lobe resection
Primary outcomes (1)
- measure
- Positioning success rate
- timeFrame
- Immediately after resection
- description
- When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases
Secondary outcomes (2)
- measure
- Procedure time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Subjects should meet all of the following criteria * diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon. * commit to follow the research procedures and cooperate with the implementation of the whole process research * 1 / 3 of pulmonary nodules are located in the periphery of the lung * signed informed consent with date Exclusion Criteria: * the target lesion is close to the hilar or large blood vessels * subjects with FEV1 less than 1.2 in lung function * subjects with cardiac function III and cardiac function IV (NYHA, New York) * subjects with uncontrollable acute pleura infection * patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side * Other factors that investigators disagree enrollment.
References
Publications (2)
- DERIVEDLi C, Ji A, Jian Z, Zheng Y, Feng X, Guo W, Lerut T, Lin J, Li H. Augmented reality navigation-guided intraoperative pulmonary nodule localization: a pilot study. Transl Lung Cancer Res. 2023 Aug 30;12(8):1728-1737. doi: 10.21037/tlcr-23-201. Epub 2023 Aug 4. PMID 37691871
- DERIVEDLi C, Zheng Y, Yuan Y, Li H. Augmented reality navigation-guided pulmonary nodule localization in a canine model. Transl Lung Cancer Res. 2021 Nov;10(11):4152-4160. doi: 10.21037/tlcr-21-618. PMID 35004246