Skip to content

Post-market clinical follow-up study plan for disposable endoscopic linear cutter stapler

Post-market clinical follow-up study plan for disposable endoscopic linear cutter stapler/ AKYQDB, AKYQDD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091930
Enrollment
Unknown
Registered
2024-11-06
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

None

Interventions

Case series:None

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age unlimited and gender unlimited; 2) The surgery type shall be endoscopic surgery; 3) The departments of surgical procedures: general and thoracic surgical procedures; 4) Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3

Exclusion criteria

Exclusion criteria: 1) Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen; 2) Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site; 3) Surgery record is incomplete, unable to extract main indicators related information.

Design outcomes

Primary

MeasureTime frame
Anastomosis success rate;

Secondary

MeasureTime frame
Operation time;Amount of intraoperative blood loss;Intraoperative conversion (caused by the stapler and/or cartridge);Length of hospitalization;All-cause re-hospitalization rate (within 6 months);

Countries

China

Contacts

Public ContactChen rong

The Third Affiliated Hospital of Guangzhou Medical University

Kanxigua@163.com+86 189 2247 7847

Outcome results

None listed

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