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Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis

NCT ID: NCT05320029

Last Updated: 2023-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2022-01-20

Brief Summary

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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

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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

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Gastrointestinal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients randomized to the trial group and the control group will not cross use the product
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
A test method in which subjects are not told whether they are a trial device or a control device in order to control intentional or unintentional bias in the course of a clinical trial and in the interpretation of results

Study Groups

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Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Group Type EXPERIMENTAL

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Intervention Type DEVICE

Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Group Type ACTIVE_COMPARATOR

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Intervention Type DEVICE

Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

Interventions

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Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment

Intervention Type DEVICE

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fengh Medical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qing Ni

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Yangzhou

Locations

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Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Jiangyin, Jiangsu, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20256031708

Identifier Type: -

Identifier Source: org_study_id