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

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

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

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms
• Intervention / Treatment: Device: LungBrella marker implantation and VATS partial lobe resection

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; 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	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Collect total procedure time for lung localization and surgical resection.	Duration of procedure
Complications	Procedure-related complications will be recorded.	One month

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Shanghai Futuo Zhida Medical Technology Co., Ltd
• Investigators: Study Chair: Hecheng Li, MD&PHD, Ruijin Hospital

Publications and helpful links

General Publications

• Li C, Zheng Y, Yuan Y, Li H. Augmented reality navigation-guided pulmonary nodule localization in a canine model. Transl Lung Cancer Res. 2021 Nov;10(11):4152-4160. doi: 10.21037/tlcr-21-618.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): October 21, 2020
• Study Completion (Actual): October 21, 2020

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: ground glass opacity; lung neoplasm; localization of lung nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: RTS-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No