Clinical trial · Interventional
Evaluation of the Safety and Effectiveness of the Tri-staple Technology inThoracic Surgery Clinical Investigation
NCT07354854CI-TRIAL-00101307completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thoracic surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ezisurg stapler
- interventionNames
- Device: thoracic surgery
Primary outcomes (1)
- measure
- Anastomosis success rate
- timeFrame
- Perioperative/Periprocedural
- description
- Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage.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 outcomes (5)
- measure
- operative time
- timeFrame
- Perioperative/Periprocedural
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.