Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components

NCT06555276 | Not Yet Recruiting

• 1 other identifier: CN-ED-CTP
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.

Conditions

Gastric Disease

Keywords

stapler; anastomosis

Outcome Measures

Primary Outcomes (1)

• anastomosis success rate

  According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100%

  within six months after surgery

Interventions

Disposable endoscope linear cutting stapler and components DEVICE

to use the study device for excision, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who need open or endoscopic surgery using the study device for resection, transection and anastomosis for liver, bronchial tissue, stomach and intestines. Those who meet the inclusion criteria and don't meet the exclusion criteria will be enrolled.

You may qualify if:

• gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
• use the study device during surgery

You may not qualify if:

• patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;

Sponsors & Collaborators

• Suzhou Kerui Medical Technology Co., Ltd: lead
• Jiangsu Channel Medical Device Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• zhengliang Tu

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhengliang Tu

CONTACT

13600513557; tuzhl@sina.com

Tao Zhang

CONTACT

13500206389

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: August 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)