Lung Cancer (Diagnosis)
Conditions
Brief summary
The goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications. Participants will undergoing thoracic surgery.
Interventions
DEVICEthoracic surgery
thoracic surgery using the easyEndo™ Lite Linear Cuting Stapler for Single Use and Loading Unites for Single Use for tissue cutting and suturing.
Sponsors
Ezisurg Medical Co. Ltd.
Jinhua Municipal Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Older than 18 years old, male or female; 2. Subjects are scheduled to undergo open or thoracoscopic puimonary surgery with any surgicalprocedure; 3. The surgery is performed using the easyEndotm Lite Linear Cuting Stapler for Single Use andLoading Unites for Single Use for tissue cutting and suturing.
Exclusion criteria
1. Non-elective surgery; 2. Previous surgical operation on the ipsilateral lung; 3. Pregnant or lactating women; 4. Patients who, in the judgment of the investigator, are unsuitable to participate in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomosis success rate | Perioperative/Periprocedural | Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage. if the anastomosis is complete and there is no air leakage, the anastomosis is considered successful.other wise it is considered failed. |
Secondary
| Measure | Time frame |
|---|---|
| operative time | Perioperative/Periprocedural |
| intra-operative blood loss | Perioperative/Periprocedural |
| post-operative air leak | Perioperative/Periprocedural |
| incidence of conversion to open surgery due to stapler-related issues | Perioperative/Periprocedural |
| complication | Perioperative/Periprocedural |
Countries
China
Outcome results
None listed