Feasibility and Safety of a Wireless Palpator

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer; Thoracic Neoplasm
• Interventions: Device: Palpator; Device: Grasper; Device: Ultrasound; Other: Finger palpation

• Registration Number: NCT05321615
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25
• Study Start: 2024-03-01
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Grasper	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.
Study arm	Palpator	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.
Study arm	Ultrasound	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.
Study arm	Finger palpation	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.

Primary Outcome Measures

Name	Time	Method
Tumour detection	1 day	The palpator will be declared feasible of it can detect at least 80% of tumours (sensitivity) without the need for a thoracotomy.

Secondary Outcome Measures

Name	Time	Method
Adverse events	30 days	Adverse events will be recorded.
Prevention of thoracotomy	1 day	The number of patients undergoing conversion from VATS to open thoracotomy