Study for safety and reliability of Korean endoscopic knife

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0005104

Enrollment

Registered

2020-06-10

Start date

2020-06-10

Completion date

Unknown

Last updated

2020-06-15

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 : This study was designed as a single-center, open, randomized, non-inferiority test, and targeted at patients diagnosed with gastric cancer and adenomas and undergoing endoscopic resec

0: inconvenient, 10: very comfortable), complete resection, procedure time, postoperative complications (bleeding, perforation, infection), hemoglobin after procedure. By analyzing these variables, we

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults aged 20 to under 80 - Early gastric cancer or adenoma that can be resected using endoscopic resection (ESD, EMR) - American Society of Anesthesiologist (ASA) Physical Status 1-3 - Patients with good compliance - Patients who agreed to voluntarily informed consent

Exclusion criteria

Exclusion criteria: - Patients who have had partial gastrectomy before - Patients who had gastrostomy before - Patients undergoing additional resection for lesions that had previously undergone endoscopic resection - Patients with three or more lesions to undergo endoscopic submucosal dissection - Patients who received sedation within 24 hours before ESD due to other procedures - Pregnant or lactating patients - Patients who fail to obtain informed consent for any reason

Design outcomes

Primary

Measure	Time frame
Complete resection	—

Secondary

Measure	Time frame
Bleeding, perforation, infection	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Min Kwon

Keimyung University Dongsan Medical Center

Outcome results