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

NCT05320029 | Completed Results

• 1 other identifier: 20256031708
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Anastomosis Success

  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 The device is withdrawn after successful triggering.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 recorded as anastomosis failure.

  During surgery

Study Arms (2)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

EXPERIMENTAL

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

ACTIVE COMPARATOR

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Interventions

Disposable Powered Articulating Endoscopic Linear Cutter Stapler DEVICE

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

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

ECHELON Flex Powered Articulating Endoscopic Linear Cutters DEVICE

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

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject plans to perform emergency gastrointestinal surgery:
• Subjects with moderate malnutrition (BML \< 17kg / m2) and severe anemia (HB \< 60g / L):
• Subject BMI 228kg / m2;
• Subject platelet (PLT) \< 60x 109 / L or international normalized ratio (INR) \> 1.5;
• Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) \< 60%;
• Subject's cardiac ejection fraction ≤ 50%;
• 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:
• 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;

Sponsors & Collaborators

• Fengh Medical Co., Ltd.: lead

Study Sites (1)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Jiangyin, Jiangsu, 214437, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Jiao Liu
• Organization: Fengh Medical Co., Ltd.

jiao.liu@fulbrightmed.com

13815132106

Study Officials

• Qing Ni

  First People's Hospital of Yangzhou

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients randomized to the trial group and the control group will not cross use the product

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 11, 2022
• Study Start: August 30, 2018
• Primary Completion: February 11, 2020
• Study Completion: January 20, 2022
• Last Updated: December 14, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)