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A Single-Center Randomized Controlled Trial Evaluating the Impact of SigniaTM Slow Mode on Exudative Hemorrhage After Pulmonary Vessel Disection.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Diseases requiring anatomical lobectomy or segmentectomy
Date of first enrollment	29/10/2025
Target sample size	140
Countries of recruitment
Study type	Interventional
Intervention(s)	Conduct routine preoperative examinations, and if eligibility criteria are met, obtain informed consent to participate in the trial and then perform screening tests. Registration must be completed by the day before the scheduled surgery date. Randomize patients into two groups: one group will use the conventional speed setting during pulmonary vessels dissection, and the other group will use the slow mode speed setting.

Outcome(s)

Primary Outcome

Presence or absence of exudative hemorrhage from the pulmonary artery and pulmonary vein resection stumps

Secondary Outcome

Secondary efficacy endpoints 1) Grade of modified Likert scale for all pulmonary vessels resected using an automatic suturing device within the same case 2) Hemostasis method 3) Intraoperative blood loss (ml) 4) Number of automatic suturing devices used for pulmonary vessel resection (units) 5) Surgeon 6) Final surgical procedure Secondary safety endpoints Incidence of adverse events during and after surgery

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 90age old
Gender	Both
Include criteria	1) Age is between 18 and 90 years at the time of informed consent. 2) The patient is scheduled to undergo anatomical lung resection (lobectomy or segmentectomy). 3) ECOG performance status (PS) is 0-1. 4) Major organ function is preserved. 5) Preoperative chest CT examination was performed within 90 days of the scheduled surgery date. 6) Written informed consent for participation in this study has been obtained from the patient.
Exclude criteria	1) Cases scheduled for wedge resection. 2) Patients with a history of thoracic surgery on the same side. 3) Patients requiring surrogate decision-making, such as those with dementia. 4) Patients with a history of hypersensitivity or allergic reactions to the devices to be used. 5) Other cases deemed inappropriate for the safe conduct of this trial by the physician.