Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

NCT06677008 | Not Yet Recruiting

• 1 other identifier: CAK-PMCF
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.

Conditions

The Expeditious Transection/resection of Tissues and Creation of Anastomoses

Outcome Measures

Primary Outcomes (1)

• Anastomosis success rate

  The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.

  the investigation sites will be collected from January 2023 to September 2024.

Secondary Outcomes (5)

• Operation time

  The investigation sites will be collected from January 2023 to September 2024.

• Amount of intraoperative blood loss

  the investigation sites will be collected from January 2023 to September 2024.

• Intraoperative conversion (caused by the stapler and/or cartridge)

  the investigation sites will be collected from January 2023 to September 2024.

• Length of hospitalization

  the investigation sites will be collected from January 2023 to September 2024.

• All-cause re-hospitalization rate (within 6 months)

  From the date of surgery to six months after the surgery

Other Outcomes (3)

• Adverse events

  From the date of surgery to six months after the surgery

• Device deficiencies

  From the date of surgery to six months after the surgery

• Serious adverse events

  From the date of surgery to six months after the surgery

Study Arms (1)

Disposable endoscopic linear cutter stapler

Device: Disposable endoscopic linear cutter stapler

Interventions

Disposable endoscopic linear cutter stapler DEVICE

Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)

Disposable endoscopic linear cutter stapler

Eligibility Criteria

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

Study Population

For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses.

You may qualify if:

• Age unlimited and gender unlimited;
• The surgery type shall be endoscopic surgery;
• The departments of surgical procedures: general and thoracic surgical procedures;
• Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.

You may not qualify if:

• 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;
• Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
• Surgery record is incomplete, unable to extract main indicators related information.

Sponsors & Collaborators

• Suzhou Kerui Medical Technology Co., Ltd: lead

Study Sites (1)

Disposable endoscopic linear cutter stapler

Wujin District, Changzhou, China

Location

Central Study Contacts

Ke Zhou

CONTACT

+86 18118447767; ke.zhou@care-real.com

Study Design

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

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: November 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)