Feasibility and Safety of a Wireless Palpator

NCT ID: NCT05321615

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-15

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.

Conditions

Lung Cancer; Thoracic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study arm

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.

Group Type: OTHER

Palpator

Intervention Type: DEVICE

Palpator for tumor localization

Grasper

Intervention Type: DEVICE

Atraumatic lung grasper

Ultrasound

Intervention Type: DEVICE

VATS ultrasound

Finger palpation

Intervention Type: OTHER

Palpation of the lung/tumour using the surgeon's finger

Interventions

Palpator

Palpator for tumor localization

Intervention Type: DEVICE

Grasper

Atraumatic lung grasper

Intervention Type: DEVICE

Ultrasound

VATS ultrasound

Intervention Type: DEVICE

Finger palpation

Palpation of the lung/tumour using the surgeon's finger

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Richard Malthaner

Chair Chief Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Deb Lewis

Role: CONTACT

deb.lewis@lhsc.on.ca

519-685-8500 ext. 75685

Other Identifiers

Palpator 2022-02-22

Identifier Type: -

Identifier Source: org_study_id