Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial

Status: Recruiting
Location: See location...
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:

• Male or female ≥ 18years of age;

• There was no distant metastasis in preoperative clinical evaluation;

• The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;

• Target lung nodule diameter ≤ 2cm

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

• preoperative ECOG physical state score 0/1;

• Volunteer to participate in the study and sign the informed consent form.

Locations
Other Locations
China
Zuodong Song
RECRUITING
Shanghai
Contact Information
Primary
Xinghua Cheng, MD
chengxinghua_001@163.com
+8617701681215
Backup
Xinghua Cheng
chengxinghua_001@163.com
+8617701681215
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2024-03
Participants
Target number of participants: 74
Treatments
Experimental: mixed reality guided localization group
Application of mixed reality technique for percutaneous lung nodule localization.
No_intervention: Computerized tomography (CT) guided localization 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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