Clinical trial · Interventional
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
A Prospective, Multicenter, Single Group Clinical Study to Evaluate the Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of 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)
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure. The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary surgical markers to localize pulmonary nodules in subjects prior to the resection of pulmonary nodules by video-assisted thoracoscopic surgery (VATS).
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 |
|---|---|---|---|
| Disposable Pulmonary Surgical Marker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Disposable Pulmonary Surgical Marker
- description
- Locate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS.
- interventionNames
- Device: Disposable Pulmonary Surgical Marker
Primary outcomes (1)
- measure
- Positioning success rate
- timeFrame
- Immediately after VATS
- description
- The proportion of patients who complete VATS resection of target pulmonary nodules/number of patients receiving localization of target pulmonary nodules before operation, expressed as "rate", will be evaluated during and immediately after surgery to evaluate the effectiveness of disposable pulmonary surgical markers in the localization of pulmonary nodules in surgery.
Secondary outcomes (6)
- measure
- Positioning success rate (in terms of marker placement)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 years old； * Pulmonary nodule, which satisfying any of the following Criteria: * solid nodules with diameter ≤1 cm or solid component ≤1 cm non-purely ground glass, and the distance between the solid component of the nodule and the visceral pleural\>0.5cm; * Pure ground glass opacity (pGGO)； * Before VATS operation, the doctor judge that the nodule is difficult to locate during the operation. * Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed; * Preoperative evaluation shows that placing marker through bronchus is feasible； * The subject is able to fully understand the requirements of clinical research; * Subject or the legal representative signs the informed consent form. Exclusion Criteria: * Contraindications for bronchoscopy; * Systemic factors: sepsis, history of repeated pulmonary infections, and any type of severe infectious disease within one month of screening； * Severe cardio and pulmonary disease； * Coagulation dysfunction, with a clear tendency to bleed; * General anesthesia contraindication; * Allergic history of nickel-titanium materials; * Breast-feeding or may be or plan to be pregnant during the trial; * Participating in clinical trials of other drugs or medical devices; * Other conditions that Investigator consider the subject to be inappropriate.
References
Publications (0)
Data not yet available