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Post-market clinical follow-up of disposable endoscope linear cutting staplers and components

Post-market clinical follow-up of disposable endoscope linear cutting staplers and components

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088987
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal disease

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Gender unlimited, age unlimited; 2) Open surgery or endoscopic surgery; 3) Surgical sites are lung, bronchial tissues, stomach and intestines. For resection, transection and anastomosis of them; 4) Use the study device during the operation (disposable endoscopic linear cutter stapler adn its components, single shaft type).

Exclusion criteria

Exclusion criteria: 1) Patients with contra-indications 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; 2) Combined with other similar products (staplers) for surgical resection, transsection and anastomosis; 3) Surgical records are incomplete, and information related to major indicators cannot be extracted; 4) Other situations that the researcher considers inappropriate for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Anastomosis success rate;

Secondary

MeasureTime frame
Operation duration;Peroperative bleeding;Intraoperative conversion (due to stapler);Duration of hospitalization;All-cause readmission rate (within 6 months);

Countries

China

Contacts

Public ContactTu Zhengliang

The First Affiliated Hospital of Zhejiang University School of Medicine

tuzhl@sina.com+86 136 0051 3557

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026