Feasibility and Safety of a Wireless Palpator

Lung Cancer Clinical Trial

— Palpator  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05321615
• Other study ID #: Palpator 2022-02-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Deb Lewis
• Phone: 519-685-8500
• Email: deb.lewis[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Thoracic Neoplasm
• Thoracic Neoplasms

Intervention

Device:
• Palpator
Palpator for tumor localization
• Grasper
Atraumatic lung grasper
• Ultrasound
VATS ultrasound

Other:
• Finger palpation
Palpation of the lung/tumour using the surgeon's finger

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevention of thoracotomy	The number of patients undergoing conversion from VATS to open thoracotomy	1 day
Secondary	Adverse events	Adverse events will be recorded.	30 days