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A Clinical Study on Ultrasonic Energy Devices for Surgical Applications Developed with Domestic Technology

A Clinical Study on Ultrasonic Energy Devices for Surgical Applications Developed with Domestic Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006314
Enrollment
30
Registered
2021-07-02
Start date
2021-07-21
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

None listed

Interventions

Medical Device : Comparison of 3 surgical energy devices used for tissue resection or vascular ligation in gastric cancer patients. Test group (domestic medical devices), Control group 1 (previously u

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged between 20 and 75 years of age; 2) Patients diagnosed with gastroscopic biopsy with gastric cancer (adenocarcinoma) 3) Patients with an ECOG performance status of 0 or 1 4) Patients who have not received chemotherapy or radiation treatment prior to surgery 5) Patients who have not taken anticoagulation agent prior to surgery 6) Patients with no previous abdominal surgery 7) Patients capable of laparoscopic and robotic surgery 8) Patients who outline the research and receive an informed consent form (Regulation Form) from the patient themselves in principle; However, if necessary in patients older than 70 years of age, study subjects can understand research-related information (e.g., study nature and expected findings), handle information about the study logically, and clearly express their choices about whether or not they want to participate. If necessary, they are also equipped with appropriate protection, such as obtaining their consent with their family members or legal representatives.

Exclusion criteria

Exclusion criteria: 1) If the patient or guardian does not agree with this study 2) Patients subject to open surgery 3) If you have been treated for another organ cancer before being diagnosed with stomach cancer or currently accompanied by another cancer 4) More than one lesion site 5) Where chemotherapy or radiation treatment has been received in the past; 6) Preoperative examination confirms remote metastasis 7) For residual cancer 8) Metastatic gastric cancer 9) A person who lacks medical ability, is pregnant or is planning to become pregnant;

Design outcomes

Primary

MeasureTime frame
Investigate advantages and disadvantages of using domestic energy devices

Secondary

MeasureTime frame
Check the non-feriority of domestic devices compared to foreign devices

Countries

Korea, Republic of

Contacts

Public ContactSo Jung KIM

The Catholic University of Korea, Seoul St. Mary's Hospital

somang421@gmail.com+82-2-2258-6339

Outcome results

None listed

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