Comparison of the Clear Coajet Hemostatic effect on EMR and ESD

A multicenter, open-label, randomized prospective study to compare the haemostatic effect of Clear Coajet during Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007744

Enrollment

404

Registered

2022-09-29

Start date

2022-09-19

Completion date

Unknown

Last updated

2025-11-17

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 : When endoscopic resection(endoscopic mucosal resection or endoscopic submucosal dissection) is performed, saline is injected into the submucosa below the lesion to separate the lesion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Men and women between the ages of 18 and 85 (2) A sessile polyp larger than 1.5 cm or a lateral spreading tumor, that is decided to perform endoscopic mucosal resection or endoscopic submucosal dissection (3) A person who has signed a written informed consent form to participate in this study

Exclusion criteria

Exclusion criteria: (1) Pedunculated polyp (2) Patients with Coagulopathy (international normalized ratio >1.5, a partial thromboplastin time >45 s, or a platelet count <80,000/mL)

Design outcomes

Primary

Measure	Time frame
Clear Coajet effectiveness on hemostasis of intraoperative bleeding during endoscopic mucosal resection or endoscopic submucosal dissection, hemostasis success rate, time taken to hemostasis, In case you need to use other endoscopic devices such as coagulation forceps or hemoclips for additional hemostasis	—

Secondary

Measure	Time frame
Incidence rate of side effects in both groups (such as bleeding and perforation, which are major side effects) should be investigated. Therefore, accompanied symptoms should be investigated such as melena, decreased hemoglobin level of 2 g/dL or more, dizziness, fever, nausea, vomiting, anorexia etc, Delayed bleeding rate within 30 days after resection, Tumor recurrence rate at follow-up endoscopy after 1 year	—

Measure

Time frame

Incidence rate of side effects in both groups (such as bleeding and perforation, which are major side effects) should be investigated. Therefore, accompanied symptoms should be investigated such as melena, decreased hemoglobin level of 2 g/dL or more, dizziness, fever, nausea, vomiting, anorexia etc, Delayed bleeding rate within 30 days after resection, Tumor recurrence rate at follow-up endoscopy after 1 year

—

Countries

Korea, Republic of

Contacts

Public ContactHanHee Lee

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

hanyee99@hanmail.net+82-2-3779-1519

Outcome results