Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060933) titled 'A prospective study evaluating the feasibility and operability of i-Lung, a three-dimensional lung model intraoperative reference system in thoracoscopic lung resection' on March 13.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokushima university

Condition: Condition - Diseases requiring thoracoscopic anatomical lung resection Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study prospectively evaluates the feasibility, operability, and safety of using the i-Lung 3D simulator for VATS during intraoperative surgery. It will verify the "ability to complete the operation" and the "contribution to the surgeon's anatomical understanding" when operating the system using a game controller within the sterile field during surgery. The evaluation will be conducted through questionnaires administered to surgeons and assistants who participated in the surgery and operated i-Lung. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - During surgery, images from i-Lung are displayed on the operating room monitor, and the surgeon manipulates the model using a control device fitted with a sterile cover.

The i-Lung used in this study is an unapproved medical device that has not obtained manufacturing and marketing approval under the Pharmaceuticals and Medical Devices Act. This system is used for the purpose of presenting clinical support information during surgery; the final decisions regarding surgical procedure selection, vascular and bronchial treatment, etc., will be made by the surgeon based on conventional surgical field findings and existing image information.

Furthermore, if it is determined that the use of this system may affect the progress of the surgery, its use will be immediately discontinued and the normal surgical procedure will be continued.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 or older Patients scheduled for thoracoscopic lung resection Patients for whom written informed consent can be obtained Key exclusion criteria - Patients who could not provide written consent Patients deemed unsuitable by the principal investigator Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 13 Day Anticipated trial start date - 2026 Year 04 Month 20 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069731

Disclaimer: Curated by HT Syndication.