NCT05321615

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Thoracic Neoplasm

Interventions

Type	Name	Description
DEVICE	Palpator	Palpator for tumor localization
DEVICE	Grasper	Atraumatic lung grasper
DEVICE	Ultrasound	VATS ultrasound
OTHER	Finger palpation	Palpation of the lung/tumour using the surgeon's finger

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2022-04-11
• Last updated: 2023-10-25