N/A
N=164
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Gastrointestinal Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT05320029 ↗Enrolled (actual)
164
Serious AEs
12.5%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Anastomosis Success — 80; 80 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler (Device); ECHELON Flex Powered Articulating Endoscopic Linear Cutters (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fengh Medical Co., Ltd.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anastomosis Success |
80; 80 | <0.05 sig |
Summary
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
Eligibility Criteria
Inclusion Criteria
- The subjects are 18 ~ 75 years old, regardless of gender:
- Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis:
- 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
- The subject plans to perform emergency gastrointestinal surgery:
- Subjects with moderate malnutrition (BML 1.5;
- Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) 10.0mmol/l before operation:
- 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
- Subjects participated in clinical trials of other drugs or devices within 3 months before the trial;
- Other conditions that the researchers judged not suitable for inclusion.
Data sourced from ClinicalTrials.gov (NCT05320029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.