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A prospective single-arm clinical study to evaluate the efficacy and safety of EasyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges in thoracic surgery

A prospective single-arm clinical study to evaluate the efficacy and safety of EasyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges in thoracic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085821
Enrollment
Unknown
Registered
2024-06-19
Start date
2024-06-24
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

pulmonary disease

Interventions

Stapler treatment group:Stapler

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 80 years old, regardless of gender; (2) Subjects are scheduled to undergo open or thoracoscopic lung surgery, with no limitation on surgical methods; (3) American Society of Anesthesiologists (ASA) score <3; (4) The subject or his/her guardian is able to understand the purpose of the study, have sufficient willingness to follow the study protocol, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Subject is in active (subject is currently receiving systemic therapy) bacterial infection or fungal infection; (2) Systemic steroid medication (intravenous or oral) within 30 days prior to surgery; (3) Chemotherapy, radiotherapy or other neoadjuvant therapy within 30 days before surgery; (4) subject's one-second forced expiratory volume (FEV1)/expected value =50%, or one-second forced expiratory volume (FEV1)/forced vital capacity (FVC) =60%; (5) NYHA (New York Heart Association) cardiac function grade IV; (6) Surgery has been performed on the lungs; (7) Pregnant or lactating women; (8) Combined use of other stapler products other than test equipment;

Design outcomes

Primary

MeasureTime frame
Prolonged air leakage;Satisfaction with the performance of surgical instruments post-operation;

Secondary

MeasureTime frame
Surgical situation (intraoperative blood loss, intraoperative air leakage);Pre-discharge recovery status of the subject;Recovery status of the subject 30 days post-surgery;

Countries

China

Contacts

Public ContactFang Wentao

Shanghai Chest Hospital

vwfang@hotmail.com+86 139 0186 7516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026