Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06335563
NA

Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

Summary

This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.

Official title: Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2024-03-14

Completion Date

2024-12-01

Last Updated

2024-04-12

Healthy Volunteers

No

Interventions

PROCEDURE

AR glasses-assisted pulmonary nodule puncture localization

Combined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.

PROCEDURE

CT-guided pulmonary nodule puncture localization

Positioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China