Clinical trial · Interventional
Image - Navigated Resection of Lung Nodules
NCT04702165CI-TRIAL-00092759completedPhase 1 / Phase 2ClinicalTrials.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 is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will assist the surgeon in both the location and resection of the lung nodule under real-time guidance.
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 Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lung resection with Lung Resection Marker Locator Kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VATS resection with J-bar
- description
- Each patient with a lung nodule meeting criteria will undergo a lung resection which could be one of three approaches: iVATS with Dyna-CT, VATS, or open. Each approach will use a the experimental device the Lung Resection Marker Locator Kit
- interventionNames
- Device: lung resection with Lung Resection Marker Locator Kit
Primary outcomes (1)
- measure
- To compare the measurements from the J-bar fiducial to the first staple line obtained by the device in vivo to that performed in the frozen section room on the lung specimen obtained (which includes both the J bar and the staple line).
- timeFrame
- 1 day
- description
- device feasibility
Secondary outcomes (3)
- measure
- whether coefficient is needed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males or females aged 21 years or older as it is extremely rare for younger people to be at risk for lung cancers. 2. Be deemed candidates for the lung resection surgery, which will be determined by their treating Thoracic Surgeon (also a physician investigator) 3. Have lesions that are nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension using conventional techniques 4. Seen at BWH Thoracic Surgery outpatient clinics or as inpatient (Note: Subjects will be formally consented to the study at BWH only) Exclusion Criteria: 1. Female subjects pregnant or breastfeeding 2. Subjects with a pacemaker or equivalent devices (AICD) due to the use of electromagnetic tracking generator. 3. Patients who are not scheduled for lung surgery \-
References
Publications (0)
Data not yet available
No reference posted for this study.