Feasibility and Safety of a Wireless Palpator

Lawson Health Research Institute

Status: Not yet enrolling

Conditions: Thoracic Neoplasm; Lung Cancer

Treatments: Device: Ultrasound; Device: Palpator; Device: Grasper; Other: Finger palpation

Study type: Interventional

Funder types: Other

Identifiers

NCT05321615

Palpator 2022-02-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Study arm

Other group

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.

Treatment:

Other: Finger palpation

Device: Grasper

Device: Palpator

Device: Ultrasound