easyEndoTM Lite Staplers and Loading Units in Thoracic Su... | NCT07345013

Studies
easyEndoTM Lite Staplers and Loading Units in Thoracic Surgery

NCT07345013

Sponsor

Ezisurg Medical Co. Ltd.

Status

Completed

Last Update Posted

Jan 15, 2026Actual

Enrollment

900Actual

Phase

Not Applicable

Conditions

Thoracic Surgery

Interventions

easyEndoTM Lite linear cutting stapler and loading units

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2021Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Dec 17, 2025

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

900Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
easyEndoTM Lite linear cutting stapler and loading units	Experimental		Device: easyEndoTM Lite linear cutting stapler and loading units

Interventions

Name	Type	Description	Arm Group Labels	Other Names
easyEndoTM Lite linear cutting stapler and loading units	Device	using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery	easyEndoTM Lite linear cutting stapler and loading units

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stapling success rate	No intrate-operative and post-operative air-leak	Perioperative/Periprocedural

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative blood loss		Perioperative/Periprocedural
Rate of convert to open surgery		Perioperative/Periprocedural
Hospitalization time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital		Fuzhou	Fujian	350300	China