Clinical trial · Interventional
Feasibility and Safety of a Wireless Palpator
A Prospective Study to Assess the Feasibility and Safety of a Wireless Palpator to Detect Occult Subpleural Lung Tumours in Humans During Minimally Invasive (VATS) Lung Resection.
NCT05321615CI-TRIAL-00070766PalpatorunknownN/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)
Evaluation of the ability of the Palpator to detect hidden (occult) lung tumours that cannot be visualized or palpated using the traditional methods of visual inspection, grasper palpation, and VATS ultrasound.
Conditions
Conditions (2)
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 |
| Thoracic Neoplasm | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Finger palpation | Other | — | UNRESOLVED |
| Grasper | Device | — | UNRESOLVED |
| Palpator | Device | — | UNRESOLVED |
| Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Study arm
- description
- All patients will undergo a standard VATS pleuroscopy to visually search for the nodule and its position. Sequential assessment using a grasper, the Palpator, the VATS ultrasound probe, and then finger palpation will be done to detect the nodule.
- interventionNames
- Device: Palpator
- Device: Grasper
- Device: Ultrasound
- Other: Finger palpation
Primary outcomes (1)
- measure
- Tumour detection
- timeFrame
- 1 day
- description
- The palpator will be declared feasible of it can detect at least 80% of tumours (sensitivity) without the need for a thoracotomy.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Peripheral occult sub-pleural (\>5 mm) solitary lung nodule \< 50 mm on CT scan scheduled for surgical removal using a VATS approach Exclusion Criteria: * Semi-solid nodules (ground glass nodule). * Pregnancy or potentially pregnant women. * Mentally challenged. * Inability to consent for the study. * Patients less than 18 years old. * Patients with pulmonary nodules easily located during VATS (\> 50 mm, pleural puckering, invading chest wall) * Patients who have chest anatomy precluding VATS resection.
References
Publications (0)
Data not yet available
No reference posted for this study.