Trials / Completed
CompletedNCT05320029
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Fengh Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Detailed description
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson \& Johnson.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment |
| DEVICE | ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment |
Timeline
- Start date
- 2018-08-30
- Primary completion
- 2020-02-11
- Completion
- 2022-01-20
- First posted
- 2022-04-11
- Last updated
- 2023-12-14
- Results posted
- 2023-11-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05320029. Inclusion in this directory is not an endorsement.