Feasibility and Safety of a Wireless Palpator

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
All procedures will be performed with the patient under general anesthesia with single lung ventilation through double-lumen endotracheal intubation. Three to four thoracoports, no larger than 12 mm, will be inserted in the intercostal spaces as needed. After VATS port placement, the pleural cavity will be insufflated with CO2 to a maximum pressure of 8 mm Hg to assist with lung deflation. A standard VATS pleuroscopy will be performed to visually search for the nodule and its position confirmed with sequential assessment using a grasper, the Palpator, the VATS ultrasound probe, and then finger palpation. This will ensure that all patients will have the opportunity to avoid a large thoracotomy if the lesion can't be identified by the Palpator. If the lesion can be detected either visually or by grasper palpation, this information will be recorded, but will be excluded from the analysis of Palpator feasibility.

Official Title
-----------------
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.

Conditions
-----------------
Lung Cancer, Thoracic Neoplasm

Intervention / Treatment
-----------------
* Device: Palpator
* Device: Grasper
* Device: Ultrasound
* Other: Finger palpation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study arm<br>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. | Device: Palpator<br>* Palpator for tumor localization<br>Device: Grasper<br>* Atraumatic lung grasper<br>Device: Ultrasound<br>* VATS ultrasound<br>Other: Finger palpation<br>* Palpation of the lung/tumour using the surgeon's finger<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour detection | The palpator will be declared feasible of it can detect at least 80% of tumours (sensitivity) without the need for a thoracotomy. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of thoracotomy | The number of patients undergoing conversion from VATS to open thoracotomy | 1 day | 
| Adverse events | Adverse events will be recorded. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palpation, Tactile image sensor, Lung ultrasound, VATS procedures