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Completed

NCT Number: NCT04211051

Safety and Feasibility of 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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LungBrella marker implantation and VATS partial lobe resection

Device

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 .

Primary outcomes

  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 outcomes

  1. Procedure time

    Time frame: Duration of procedure

    Collect total procedure time for lung localization and surgical resection.

  2. Complications

    Time frame: One month

    Procedure-related complications will be recorded.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai Futuo Zhida Medical Technology Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2019
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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