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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06335563
Other study ID # STAR009
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 14, 2024
Est. completion date December 1, 2024

Study information

Verified date April 2024
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact Yunlang She, MD
Phone +86 17749739242
Email sylxan3344@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
China Shanghai Pulmonary Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of puncture localization of pulmonary nodules Quantified as the shortest distance from the actual position of the puncture needle tip to the originally planned puncture point Intraoperative
Secondary Success rate of puncture localization of pulmonary nodules The puncture is defined as successful when the distance between the actual localizing point of the puncture needle tip and the center of the localized nodule does not exceed 20 mm. Intraoperative
Secondary Adjust the number of needle punctures Number of needle insertion attempts required for successful localizing Intraoperative
Secondary Operating time The time span from the patient's first CT scan to the last CT scan, in minutes Intraoperative
Secondary Radiation dose The length product value of the radiation dose recorded by the CT scanner, measured in mGy * cm Intraoperative
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