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The Efficacy of Intraoperative Pulmonary Nodules Localization Guided by Virtual Reality Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529603
Recruitment Status : Withdrawn (The previous studies did not show convincing results of this technology.)
First Posted : August 27, 2020
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
Shanghai Futuo Zhida Medical Technology Co., Ltd
Information provided by (Responsible Party):
Hecheng Li M.D., Ph.D, Ruijin Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Lung Neoplasm Device: LungBrella marker implantation and VATS partial lobe resection Not Applicable

Detailed Description:
This is a prospective, mulitiple-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 90 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Localizing of Intraoperative Pulmonary Nodules Guided by Virtual Reality Technology
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
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 .


Outcome Measures
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Primary Outcome Measures :
  1. Positioning success rate [ Time Frame: Immediately after resection ]
    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


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: Duration of procedure ]
    Collect total procedure time for lung localization and surgical resection.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529603


Locations
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China, Shanghai
Ruijin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Shanghai Futuo Zhida Medical Technology Co., Ltd
Investigators
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Principal Investigator: Hecheng Li Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: Hecheng Li M.D., Ph.D, Chair of thoracic department, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04529603    
Other Study ID Numbers: RTS-012
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hecheng Li M.D., Ph.D, Ruijin Hospital:
Lung Neoplasm
localization of lung nodules
ground glass opacity
sublobar resection
Additional relevant MeSH terms:
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Lung Neoplasms
Multiple Pulmonary Nodules
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases