Feasibility and Safety of a Wireless Palpator
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.
1 other identifier
interventional
22
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Mar 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedOctober 25, 2023
October 1, 2023
1.8 years
February 23, 2022
October 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Prevention of thoracotomy
1 day
Adverse events
30 days
Study Arms (1)
Study arm
OTHERAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair Chief Thoracic Surgery
Study Record Dates
First Submitted
February 23, 2022
First Posted
April 11, 2022
Study Start
March 1, 2024
Primary Completion
December 15, 2025
Study Completion
December 15, 2025
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
no plan