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

NCT ID: NCT06677008

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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The Expeditious Transection/resection of Tissues and Creation of Anastomoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Disposable endoscopic linear cutter stapler

Disposable endoscopic linear cutter stapler

Intervention Type DEVICE

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

Interventions

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Disposable endoscopic linear cutter stapler

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Kerui Medical Technology Co., Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Disposable endoscopic linear cutter stapler

Wujin District, Changzhou, China

Site Status

Countries

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China

Central Contacts

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Ke Zhou

Role: CONTACT

+86 18118447767

Facility Contacts

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Xiaohong Xu

Role: primary

+86 13915015530

Other Identifiers

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CAK-PMCF

Identifier Type: -

Identifier Source: org_study_id

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