Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
CompletedNAResults postedLast updated 14 December 2023
What this trial tests
NA trial testing Disposable Powered Articulating Endoscopic Linear Cutter Stapler in Gastrointestinal Neoplasm in 164 participants. Completed in 20 January 2022.
Timeline
30 August 2018
Primary endpoint 11 February 2020
20 January 2022
Quick facts
Lead sponsor
Fengh Medical Co., Ltd.
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
quadruple
Primary purpose
treatment
Enrollment
164
Start date
30 August 2018
Primary completion
11 February 2020
Estimated completion
20 January 2022
Sites
1 location across China
Drugs / interventions tested
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Adults 18 to 75, any sex, with Gastrointestinal Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Anastomosis SuccessPrimary· During surgery
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is rec
Group
Value
95% CI
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
80
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
80
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Serious: 11/80 (14%)
Deaths: 0/80
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fengh Medical Co., Ltd.
Last refreshed: 14 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05320029.