Clinical trial NCT05320029: Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Official title: Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Neoplasm
Lead sponsor: Fengh Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to the trial group and the control group will not cross use the product
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Anastomosis Success
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jiangyin
country: China
facility: Disposable Powered Articulating Endoscopic Linear Cutter Stapler
state: Jiangsu
Study officials:
affiliation: First People's Hospital of Yangzhou
name: Qing Ni
role: PRINCIPAL_INVESTIGATOR
References: