Comparative study with an external control to evaluate the air leak control function with a new surgical stapler (Echelon 3000) in anatomical lung resection.

Comparative study with an external control to evaluate the air leak control function with a new surgical stapler (Echelon 3000) in anatomical lung resection. - AIRSTOP Echelon 3000

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032250303

Enrollment

Registered

2025-08-20

Start date

2025-08-20

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

Pulmonary diseases who require anatomical pulmonary resection lung cancer, lung tumor

Interventions

Lungs are resected using a new surgical staplers (Echelon 3000).

D013528

Surgical staplers

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1) Aged 18to 90 years; 2) Patients who were scheduled to undergo anatomical pulmonary resection (lobectomy or segmentectomy) using surgical staplers; 3) Patients with incomplete interlobar fissures on preoperative chest computed tomography (CT) who were coniderd to require pulmonary resection involving the use of surgical staplers; 4) Patents with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5) Patients with preserved main organ function; 6) Patients fully informed of the study and who provide informed and voluntary written consent for participation.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients undergoing pulmonary partial resection; 2) Patients requiring multiple lobectomy or segmentectomy; 3) Patients who were considered to have complete interlobar fissures on preoperative chest CT and not to require pulmonary resection involving the use of an automatic suturing device; 4) Patients with dementia or other conditions that require consent from their legally authorized representatives; and 5) Patients with known allergies to the study materials; 6) Patients deemed by the investigator to be unsuitable for safe participation in this study.

Design outcomes

Primary

Measure	Time frame
The incidence of intraoperative stapler-related air leakage.	—

Secondary

Measure	Time frame
The secondary endpoints are as follows: (1) Time required to repair the intraoperative air leakage; (2) Duration of postoperative chest tube placement; (3) Presence or absence of postoperative persistent air leakage, presence or absence of additional treatment for persistent air leakage; (4) Incidence of delayed air leakage; (5) Presence or absence of air leakage during and after surgery; (6) Incidence of intraoperative air leakage, postoperative air leakage, and delayed air leakage depending on the surgical procedures; and (7) Number of automatic suturing devices used in pulmonary resection. [Secondary safety endpoints] Incidence of adverse events during and after surgery	—

Measure

Time frame

The secondary endpoints are as follows: (1) Time required to repair the intraoperative air leakage; (2) Duration of postoperative chest tube placement; (3) Presence or absence of postoperative persistent air leakage, presence or absence of additional treatment for persistent air leakage; (4) Incidence of delayed air leakage; (5) Presence or absence of air leakage during and after surgery; (6) Incidence of intraoperative air leakage, postoperative air leakage, and delayed air leakage depending on the surgical procedures; and (7) Number of automatic suturing devices used in pulmonary resection. [Secondary safety endpoints] Incidence of adverse events during and after surgery

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Contacts

Public ContactKazuhisa Tanaka

Chiba University Hospital

katanaka-ths@chiba-u.jp+81-43-222-7171

Outcome results

None listed

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