Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules

Shanghai Jiao Tong University

Status: Completed

Conditions: Lung Neoplasms

Treatments: Device: LungBrella marker implantation and VATS partial lobe resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04211051

RTS-009

Details and patient eligibility

About

As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients

Full description

This is a prospective, single-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 10 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects should meet all of the following criteria

• diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon.
• commit to follow the research procedures and cooperate with the implementation of the whole process research
• 1 / 3 of pulmonary nodules are located in the periphery of the lung
• signed informed consent with date

Exclusion criteria

• the target lesion is close to the hilar or large blood vessels
• subjects with FEV1 less than 1.2 in lung function
• subjects with cardiac function III and cardiac function IV (NYHA, New York)
• subjects with uncontrollable acute pleura infection
• patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side
• Other factors that investigators disagree enrollment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm A

Experimental group

Description:

LungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery

Treatment:

Device: LungBrella marker implantation and VATS partial lobe resection