Clinical trial · Interventional
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
NCT06380361CI-TRIAL-00108883INSPECTcompletedN/AResults postedClinicalTrials.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 objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses.
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 |
|---|---|---|---|
| BioSpy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients will be allocated to the same study arm.
- description
- During the bronchoscopic biopsy procedure, the study device will be entered through the bronchoscope to the level of the lesion. At lesion level, the BioSpy System sensor will make several measurements of the tumors and peripheral lung nodules and masses.
- interventionNames
- Device: BioSpy System
Primary outcomes (1)
- measure
- The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.
- timeFrame
- During the bronchoscopy procedure, up to 79 minutes
- description
- The primary endpoint was defined as the proportion of patients in which at least one non-anomalous biophysical measurement was obtained by the BSS in the lesion. This endpoint represents the procedural success rate being defined as the BioSpy System obtaining at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom BSS was used.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years 2. Subjects with lesions eligible for lung biopsy under general anesthesia. 3. Lesion localization: 1. Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or 2. Peripheral lesions ≥ 20 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or ultrasound analysis (RP EBUS with central localization of the ultrasound probe) during the procedure. 4. Written Informed Consent to participate in the study. Exclusion Criteria: 1. Target lesion \<10 mm for central and \<20 mm for peripheral lesions (as determined on previous imaging) 2. Contra-indication to bronchoscopy procedures 3. Contra-indication to general anesthesia 4. Any subject that is, according to the discretion of the investigator, not eligible for study participation 5. Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
References
Publications (0)
Data not yet available
No reference posted for this study.