NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042240027

Registered date:16/05/2024

Pilot study on intersegmental line identification during lung segmentectomy by video pulse wave extraction technology using non-contact vital sensing software

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMetastatic lung tumor, Primary lung cancer
Date of first enrollment03/07/2024
Target sample size5
Countries of recruitment
Study typeInterventional
Intervention(s)During pulmonary segmentectomy, intraoperative videos are captured and analyzed using the non-contact vital sensing software. Subsequently, adverse events occurring within 30 days postoperatively are monitored and verified.

Outcome(s)

Primary OutcomeThe pulse wave identification rate of the non-contact vital sensing software in areas not planned for resection.
Secondary OutcomeNon-identification rate of pulse waves by the non-contact vital sensing software in the planned resection area. Pulse wave identification rate of the non-contact vital sensing software on the lung surface before pulmonary artery and vein dissection. Adverse events within 30 days postoperatively.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) age >=18 2) ECOG performance status (PS) is 0, 1, or 2. 3) Planning a pulmonary segmentectomy. 4) Planning to use the indocyanine green (ICG) method for intersegmental line identification. 5) Major organ function other than the lungs is preserved, and the physician determines that general anesthesia is feasible. 6) The patient has given a full explanation of the study and obtained written consent prior to enrollment in the study.
Exclude criteria(1) A patient with a history of iodine sensitivity. (2) A patient with a history of hypersensitivity to components of ICG. (3) Pregnant women, breastfeeding women, and women who may be pregnant (4) Patients with a history of serious hypersensitivity (5) Patients deemed inappropriate for registration by the physician in charge.

Related Information

Contact

Public contact
Name Shinya Katsumata
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail shi.katsumata@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Yasuhisa Ohde
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail y.ode@scchr.jp
Affiliation Shizuoka Cancer Center