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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05321615
Other study ID # Palpator 2022-02-22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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