NCT07345013

Brief Summary

A retrospective, single-arm, observation study to Evaluate the clinical safety and performance of Ezisurg stapler in thoracic surgery, 900 patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

December 17, 2025

Last Update Submit

January 6, 2026

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • stapling success rate

    No intrate-operative and post-operative air-leak

    Perioperative/Periprocedural

Secondary Outcomes (5)

  • Intraoperative blood loss

    Perioperative/Periprocedural

  • Rate of convert to open surgery

    Perioperative/Periprocedural

  • Hospitalization time

    Perioperative/Periprocedural

  • Incidence of postoperative complications

    Perioperative/Periprocedural

  • Readmission rate

    30 days

Study Arms (1)

easyEndoTM Lite linear cutting stapler and loading units

EXPERIMENTAL
Device: easyEndoTM Lite linear cutting stapler and loading units

Interventions

easyEndoTM Lite linear cutting stapler and loading unitsDEVICE

using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery

easyEndoTM Lite linear cutting stapler and loading units

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
The study population were patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350300, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 15, 2026

Study Start

January 3, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

CN(1)