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Japanese

Oct. 17, 2025

Oct. 17, 2025

jRCT1032250436

A Prospective Clinical Study on the Efficacy of Intra-Thoracic Sonographic Imaging in Thoracic Surgery

Intra-thoracic Sonographic Imaging for Guidance and High-resolution Targeting in Thoracic surgery ( INSIGHT)

Suzuki Hidemi

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba, Chiba 260-8670 JAPAN

+81-43-222-7171

hidemisuzukidesu@yahoo.co.jp

Matsui Yukiko

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba, Chiba 260-8670 JAPAN

+81-43-222-7171

ykk.matsui1530@chiba-u.jp

Recruiting

Oct. 17, 2025

50

Observational

diagnostic purpose

Among the cases for thoracic surgery at the Department of Respiratory Surgery, Chiba University Hospital,
1) Patients with lung or mediastinal lesions
2) Patients with preserved major organ function
3) Patients who have given written consent to participate in this study.

1) Persons who have expressed their refusal to participate in this study through the informed consent document
2) Persons deemed unsuitable by the principal investigator

18age old over
No limit

Thoracic diseases requiring thoracic ultrasonography

Use of ultrasound equipment in the thoracic cavity during thoracic surgery.

Thoracic Neoplasms

thoracic surgery, ultrasound equipment

D013899

D013903

Availability of intraoperative identification of target lesions by intra-thoracic ultrasonography.

I. Secondary Endpoints of Efficacy
1. retrospective data (to obtain data that occur prior to the start of the study), including patient background prior to the examination and examination results will be followed to the extent possible as an exploratory endpoint.
2. findings: the size of the pulmonary nodular lesion, the distance of the lesion from the pleural surface, and ultrasound findings of the lesion will be recorded. 3.
3) Setting conditions during lesion delineation: Record the settings of the device while the tumor is being delineated. 4) Examination time: Record the duration of the examination when the probe is being moved to the lesion.
4. examination time: measure the time from insertion of the probe into the thoracic cavity to identification of the lesion; 5. record the condition of the lungs at the time of examination
5. recording the condition of the lungs at the time of examination.
6. record the examination and surgical procedures. 7.
7. time from the start of isolated pulmonary ventilation to the identification of the lesion. 8. pathological results.
8. pathologic results: results of resection margins, histology, and background pulmonary findings on pathology.

II. secondary safety endpoints
1. intraoperative adverse events are to be identified. 2.
2. verification of the cause of failure to identify the lesion by ultrasound.

FUJIFILM Corporation
Chiba University Hospital Observational Research Ethics Review Committee
1-8-1, Inohana, Chuo-ku, Chiba, Chiba 260-8670 JAPAN, Chiba

+81-43-222-7171

ykk.matsui1530@chiba-u.jp
Approval

Oct. 02, 2025

No

none