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

JRCT ID: jRCTs042240027

Registered date:16/05/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic lung tumor, Primary lung cancer
• Date of first enrollment: 03/07/2024
• Target sample size: 5
• Study type: Interventional
• 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 Outcome: The pulse wave identification rate of the non-contact vital sensing software in areas not planned for resection.

Secondary Outcome

Non-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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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

• Primary Sponsor: Ohde Yasuhisa