Clinical trial · Interventional
Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
Clinical Trial on Performance and Safety of Disposable Powered Articulating Linear Cutter Stapler and Reloads in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
NCT05329402CI-TRIAL-00076668completedN/AResults postedClinicalTrials.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)
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Thoracoscopic Anatomic Lobectomy (segmentectomy)
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 | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Device | — | UNRESOLVED |
| ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler
- description
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler
- interventionNames
- Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler
- type
- ACTIVE_COMPARATOR
- label
- ECHELON Flex Powered Articulating Endoscopic Linear Cutters
- description
- ECHELON Flex Powered Articulating Endoscopic Linear Cutters
- interventionNames
- Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Primary outcomes (1)
- measure
- Number of Participants With Anastomosis Success
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects aged 18-70 (inclusive), with no gender limitation; 2. The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment); 3. Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent. Exclusion Criteria: 1. Subjects have contraindications of video-assisted thoracoscopy; 2. The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes; 3. Subjects' platelet (PLT) \<60x 10%/L or INR \> 1.5; 4. Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%; 5. Cardiac ejection fraction ≤50%; 6. Major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) Myocardial infarction; A history of severe neurological or psychiatric illness; The presence of a serious infection before surgery that must be controlled with medication; Dissemination of activity Sexual intravascular coagulation; At high risk of blood clots); 7. The subject is a pregnant or lactating woman; 8. The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial; 9. Other conditions that the researcher judged inappropriate for inclusion. .
References
Publications (0)
Data not yet available
No reference posted for this study.