Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 18 and 80 years inclusive;

• No distant metastasis in preoperative clinical assessment;

• The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;

• Target lung nodule diameter is no more than 2 cm;

• The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;

• Non-pleural surface nodules;

• Preoperative ECOG performance status score of 0/1;

• Voluntarily participating in this study and signing an informed consent form.

Locations
Other Locations
China
the people's second hospital Hefei
RECRUITING
Hefei
Jiangyin Hospital of Traditional Chinese Medicine
RECRUITING
Jiangyin
Jining No. 1 People's Hospital.
RECRUITING
Jining
Donghai County People's Hospital
RECRUITING
Lianyungang
Shanghai Chest Hospital
RECRUITING
Shanghai
Zhongshan Hospital
RECRUITING
Shanghai
the First Hospital of Hebei Medical University
RECRUITING
Shijia Zhuang
Zhangjiagang Hospital of Traditional Chinese Medicine,
RECRUITING
Zhangjiagang
Contact Information
Primary
Xinghua Cheng, MD
chengxinghua_001@163.com
+8617701681215
Backup
Zuodong Song, MD
szd1990@hotmail.com
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 270
Treatments
Experimental: AR-guided group
Application of augmented reality technique for percutaneous lung nodule localization.
No_intervention: CT-guided group
Computerized tomography (CT) guided percutaneous lung nodule localization.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Chest Hospital

This content was sourced from clinicaltrials.gov

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