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

Primary Purpose

Lung Neoplasms

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

LungBrella marker implantation and VATS partial lobe resection

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring lung neoplasm, localization of lung nodules, ground glass opacity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedure time

Collect total procedure time for lung localization and surgical resection.

Complications

Procedure-related complications will be recorded.

Full Information

NCT ID

NCT04211051

First Posted

December 23, 2019

Last Updated

August 29, 2021

Sponsor

Ruijin Hospital

Collaborators

Shanghai Futuo Zhida Medical Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04211051

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

April 15, 2020 (Actual)

Primary Completion Date

October 21, 2020 (Actual)

Study Completion Date

October 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Shanghai Futuo Zhida Medical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

lung neoplasm, localization of lung nodules, ground glass opacity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

LungBrella marker implantation and VATS partial lobe resection

Intervention Description

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 Outcome Measure Information:

Title

Positioning success rate

Description

Time Frame

Immediately after resection

Secondary Outcome Measure Information:

Title

Procedure time

Description

Collect total procedure time for lung localization and surgical resection.

Time Frame

Duration of procedure

Title

Complications

Description

Procedure-related complications will be recorded.

Time Frame

One month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hecheng Li, MD&PHD

Organizational Affiliation

Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hecheng Li, MD&PHD

Organizational Affiliation

Ruijin Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35004246

Citation

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.

Results Reference

derived

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

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