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

NCT04211051 | Completed

• 1 other identifier: RTS-009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Neoplasms

Keywords

lung neoplasm; localization of lung nodules; ground glass opacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Procedure time

  Duration of procedure

• Complications

  One month

Study Arms (1)

Arm A

EXPERIMENTAL

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

Interventions

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 .

Arm A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• / 3 of pulmonary nodules are located in the periphery of the lung
• signed informed consent with date

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Futuo Zhida Medical Technology Co., Ltd: collaborator

Study Sites (1)

RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (2)

• Li C, Ji A, Jian Z, Zheng Y, Feng X, Guo W, Lerut T, Lin J, Li H. Augmented reality navigation-guided intraoperative pulmonary nodule localization: a pilot study. Transl Lung Cancer Res. 2023 Aug 30;12(8):1728-1737. doi: 10.21037/tlcr-23-201. Epub 2023 Aug 4.

  PMID: 37691871 DERIVED

• 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.

  PMID: 35004246 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hecheng Li, MD&PHD

  Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Hecheng Li, MD&PHD

  Ruijin Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of thoracic department

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: April 15, 2020
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

CN (1)