Clinical trial · Interventional
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
NCT05320029CI-TRIAL-00072256completedN/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 Gastrointestinal Tissue Cutting and Anastomosis
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 |
|---|---|---|---|
| Gastrointestinal Neoplasm | Digestive System Neoplasm | ALIAS | 0.90 |
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
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subjects are 18 \~ 75 years old, regardless of gender: 2. Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis: 3. The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent. Exclusion Criteria: 1. The subject plans to perform emergency gastrointestinal surgery: 2. Subjects with moderate malnutrition (BML \< 17kg / m2) and severe anemia (HB \< 60g / L): 3. Subject BMI 228kg / m2; 4. Subject platelet (PLT) \< 60x 109 / L or international normalized ratio (INR) \> 1.5; 5. Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) \< 60%; 6. Subject's cardiac ejection fraction ≤ 50%; 7. Have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum creatinine (SER) exceeds normal values Upper limit 3 times and above: subjects with fasting blood glucose value \> 10.0mmol/l before operation: 8. The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue 9. Subjects participated in clinical trials of other drugs or devices within 3 months before the trial; 10. Other conditions that the researchers judged not suitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.