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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211051
• Other study ID #: RTS-009
• Status: Completed
• Phase: N/A
• Start date: April 15, 2020
• Est. completion date: October 21, 2020

Study information

• Verified date: August 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Multiple Pulmonary Nodules

Intervention

Device:
• LungBrella marker implantation and VATS partial lobe resection
The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .

Locations

Country	Name	City	State
China	RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Futuo Zhida Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positioning success rate	When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases	Immediately after resection
Secondary	Procedure time	Collect total procedure time for lung localization and surgical resection.	Duration of procedure
Secondary	Complications	Procedure-related complications will be recorded.	One month