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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSuzhou Care-Real Medical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

combined with other similar products (staplers) for surgical site excision, 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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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%

Time frame
within six months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Care-Real Medical Technology Co., Ltd.

Lead sponsor

Jiangsu Channel Medical Device Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: