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

A single-center randomized controlled trial evaluating the usefulness of slow mode in lung vessel resection using an automatic suturing device.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032250468
Enrollment
140
Registered
2025-10-29
Start date
2025-10-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases requiring anatomical lobectomy or segmentectomy Lung cancer, Metastatic lung tumors, Infections, Benign lung tumors

Interventions

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
E04.928
thoracic surgery

Sponsors

Suzuki Hidemi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Contacts

Public ContactRyo Karita

Chiba University Hospital

cfsa6415@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026